Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent

A Multicenter, Open-label, Randomised, Comparative, Parallel-Arm, Phase II Study to Assess Efficacy and Safety of Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02888106

Enrollment

Registered

2016-09-02

Start date

2016-04-30

Completion date

2020-10-30

Last updated

2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Viral Hepatitis B With Delta-agent

Brief summary

Randomised, Comparative, Parallel-Arm Study to Assess Efficacy and Safety of Myrcludex B in Combination with Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients with Chronic Viral Hepatitis B with Delta-agent

Detailed description

This is a multicenter, open-label, randomised, comparative, active-controlled parallel-arm phase II study. The study will be conducted in Russia. The aim of this study is to explore the safety and efficacy of treatment with Myrcludex B used as a monotherapy and in combination with PEG-IFNα and Tenofovir compared to monotherapy with PEG-IFNα in patients with chronic viral hepatitis B with delta-agent, based on the achievement of undetectable viral load at the end of the follow-up period 6 months (24 weeks) after the end of treatment. The study is also aimed at investigating immunogenicity of Myrcludex B and the drug pharmacokinetics when used in combination with PEG IFN alfa-2a and with Tenofovir. It is planned to screen 110 patients, and 90 patients will be randomised in equal numbers into six treatment arms. * Arm A (n=15): PEG IFN alfa-2a 180 µg for 48 weeks * Arm B (n=15): Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks * Arm C (n=15): Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks * Arm D (n=15): Myrcludex B 2 mg for 48 weeks * Arm E (n=15): Myrcludex B 10 mg (10 mg once a day)+ PEG IFN alfa-2a 180 µg for 48 weeks * Arm F (n=15): Myrcludex B 10 mg (5 mg twice a day)+ Tenofovir for 48 weeks

Interventions

DRUGMyrcludex B

Lyophilised powder for solution for subcutaneous injection

DRUGPEG IFN alfa-2a

solution for subcutaneous injection, once per week

DRUGTenofovir

Film-coated tablets, 300 mg, per os, once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Multicenter, Open-label, Randomized, Comparative, parallel-arm phase II study

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Signed Informed Consent form. 2. Males and females 18 to 65 years of age (inclusively). 3. Patients with chronic hepatitis B (HBeAg-positive or negative) and HBsAg-positive for at least 6 months prior to Screening. 4. Positive for anti-HDV antibodies for at least 6 months prior to Screening. 5. HDV RNA-positive at Screening. 6. ALT ≥ 1 x ULN and \< 10 x ULN. 7. The patient agreed to use adequate method of contraception during the study, starting from the time of Informed Consent signing and until completion of the Follow-up Period.

Exclusion criteria

1. Intolerance or hypersensitivity to the active ingredient or other components of the study drug Myrcludex B. 2. Intolerance or hypersensitivity to interferons alfa, genetically engineered E.coli medications, polyethylene glycol or other components of peginterferon alfa-2a. 3. Previous treatment with Myrcludex B (patients with previous exposure to interferon are eligible). 4. Therapy with antiviral drugs for chronic viral hepatitis B with delta-agent over the previous 6 months. 5. Therapy with anti-tumour agents (including radiotherapy) or immunomodulatory medications (including systemic glucocorticoids) over the previous 6 months. 6. The following laboratory test results at Screening: 1. Hemoglobin \< 100 g/L 2. Leucocytes \< 3000/µL 3. Neutrophils \< 1500/µL 4. Platelets \< 90000/µL 5. Serum creatinine \>1.5 x ULN. 7. Total bilirubin \> 34.2 µM/L. Patients with higher total bilirubin may be enrolled upon consultation with the study Medical Monitor, if there is clear evidence that the elevated bilirubin is caused by Gilbert's syndrome. 8. Current or previous decompensated liver disease, including coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminaemia, ascites, and oesophageal varices haemorrhage; Child-Pugh score of B/C or ≥6 points. 9. HCV or HIV coinfection (patients with anti-HCV antibodies and no HCV RNA at Screening are eligible). 10. Hepatocellular carcinoma. 11. Signs of drug- or alcohol-induced liver disease or any other medical conditions associated with chronic liver disease (e.g. autoimmune hepatitis, hemochromatosis, thalassaemia, alcoholic hepatitis, toxic liver disease). 12. Contraindications for liver biopsy. 13. Concurrent malignancy (current diagnosed or suspected malignancy; risk of a previous malignancy recurrence). 14. Severe decompensated cardiovascular diseases, including unstable and poorly controlled conditions, over 6 months before Screening. 15. History of poorly controlled thyroid conditions or clinically significant signs of thyroid dysfunction at Screening. 16. Previous or current severe renal failure or significant renal dysfunction at Screening. 17. Previous or current chronic pulmonary disease with respiratory distortion at Screening. 18. Previous or current severe retinopathy, significant ophthalmology disorders associated with diabetes mellitus or hypertension. 19. Previous or current severe psychiatric disorders at Screening (e.g. severe depressions, suicidal attempts, severe neuroses or cognitive disorders). 20. Previous or current endocrine disorders (hypoglycaemia, hyperglycaemia, diabetes mellitus) that are not adequately controlled at Screening. 21. History of visceral organ transplantation. 22. Signs of drug and/or alcohol dependence (80 g of alcohol/day for men and 40 g of alcohol/day for women) within 1 year before Screening. 23. History of immune disorders (e.g. idiopathic thrombocytopenic purpura, lupus erythematosus, sclerodermia, severe psoriasis, rheumatoid arthritis). 24. Need for concomitant use of glucocorticoids or myelotoxic agents. 25. Participation in another clinical study within 30 days prior to enrollment into this study. 26. Pregnant or breast-feeding females. 27. Any other condition that, in the opinion of Investigator, precludes the patient from taking part in this study.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Patients With Negative HDV RNA by PCR	72 weeks	Negativation of HDV RNA by PCR (undetectable HDV RNA) at Week 72 (end of follow-up period)

Secondary

Measure	Time frame	Description
Percentage of Patients With Normalized ALT	24, 48 and 72 weeks	Percentage of patients with normalized ALT at Weeks 24, 48 and 72. ALT normalisation was defined as having an ALT value within the normal range (≤31 U/L for females and ≤41 U/L for males)
Percentage of Patients With Combined Response	24, 48 and 72 weeks	Combined response is defined as negative HDV RNA and ALT normalization at Weeks 24, 48, and 72. The criteria for combined response were HDV RNA value below LLoD (where LLoD=10 IU/ml) and ALT within normal range (≤31 U/L for females and ≤41 U/L for males)
Percentage of Patients With HВsAg Response	24, 48 and 72 weeks	HВsAg response was defined as HBsAg negativation or \> 1 log10 IU/mL decline from baseline.
Percentage of Patients With HBsAg Negativation	48 and 72 weeks	Undetectable HВsAg with appearance of HbsAg antibodies or without it.
Percentage of Patients With Negative HBV DNA by PCR	24, 48 and 72 weeks	Percentage of patients with undetectable HBV DNA by PCR at Weeks 24, 48 and 72
Percentage of Patients With Negative HDV RNA by PCR	24 and 48 weeks	Percentage of patients with negative HDV RNA by PCR (undetectable HDV RNA) at Weeks 24 and 48
Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	72 weeks	Change (improvement/ worsening) in fibrosis and histological activity stage according to the liver biopsy study results from baseline to post-treatment Liver fibrosis was evaluated by histological staging systems with stage 0 corresponding to absence of fibrosis and with the highest score (the last stage in all systems) corresponding to cirrhosis. Improvement is defined as a decrease of at least 1 point in histological staging systems; worsening is defined as an increase of at least 1 point. Data should be interpreted with caution due to low number of paired biopsies available.
Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	48 and 72 weeks	Molecular analyses of relative HDV RNA expression, relative HBV pregenomic expression, relative total HBV RNA expression (X region), relative HBV RNA expression (S region) from baseline to post-treatment. \*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.
Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	48 and 72 weeks	Molecular analyses of total HBV DNA (X region) copies/cell, HBV DNA (S region) copies/cell, cccDNA copies/cell from baseline to post-treatment. \*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.
Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment	48 and 72 weeks	Molecular analysis of HDAg positive Hepatocytes (percentage of HDAg positive Hepatocytes) from baseline to post-treatment. \*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.
Change in the Gene Expression Analyses From Baseline to Post-treatment	Weeks 48 - 72	Change in the gene expression analyses of CXCL10, NTCP, CYP7A1, ISG15, MX1, OAS, HLA-E, TAP1 and USP18 from baseline to post-treatment. Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.
The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.	48 and 72 weeks	Change in liver stiffness and intensity of liver fibrosis based on results of transient elastometry of liver at weeks 48 and 72.

Countries

Russia

Participant flow

Participants by arm

Arm	Count
Arm A PEG IFN alfa-2a 180 µg for 48 weeks	15
Arm B Myrcludex B 2 mg + PEG IFN alfa-2a 180 µg for 48 weeks	15
Arm C Myrcludex B 5 mg + PEG IFN alfa-2a 180 µg for 48 weeks	15
Arm D Myrcludex B 2 mg for 48 weeks	15
Arm E Myrcludex B 10 mg (10 mg once a day) + PEG-IFN alfa-2a 180 μg during 48 weeks	15
Arm F Myrcludex B 10 mg (5 mg twice a day) + Tenofovir during 48 weeks	15
Total	90

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG003	FG004	FG005
Overall Study	Adverse Event	2	0	0	0	0
Overall Study	Lost to Follow-up	1	0	1	0	1
Overall Study	Pregnancy	1	0	0	0	0
Overall Study	Withdrawal by Subject	1	2	1	0	0
Overall Study	Withdrawal of consent	0	0	0	1	0

Baseline characteristics

Characteristic	Arm B	Arm C	Arm D	Arm E	Arm F	Arm A	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	15 Participants	15 Participants	15 Participants	15 Participants	15 Participants	15 Participants	90 Participants
Age, Continuous	37.1 years STANDARD_DEVIATION 5.5	36.9 years STANDARD_DEVIATION 7.5	42.0 years STANDARD_DEVIATION 9.6	36.2 years STANDARD_DEVIATION 7.2	34.3 years STANDARD_DEVIATION 7.2	34.1 years STANDARD_DEVIATION 7	36.8 years STANDARD_DEVIATION 7.7
Body Mass Idex	24.83 kg/m² STANDARD_DEVIATION 3.46	24.69 kg/m² STANDARD_DEVIATION 4.18	27.02 kg/m² STANDARD_DEVIATION 3.91	24.03 kg/m² STANDARD_DEVIATION 3.21	23.48 kg/m² STANDARD_DEVIATION 3.31	23.77 kg/m² STANDARD_DEVIATION 4.68	24.64 kg/m² STANDARD_DEVIATION 3.9
Body Weight	74.29 kg STANDARD_DEVIATION 14.44	72.37 kg STANDARD_DEVIATION 11.55	82.95 kg STANDARD_DEVIATION 16.38	72.67 kg STANDARD_DEVIATION 10.01	70.53 kg STANDARD_DEVIATION 9.08	68.02 kg STANDARD_DEVIATION 14.61	73.47 kg STANDARD_DEVIATION 13.43
Height	172.5 cm STANDARD_DEVIATION 9.4	171.4 cm STANDARD_DEVIATION 6	174.6 cm STANDARD_DEVIATION 8.6	174.1 cm STANDARD_DEVIATION 8.2	173.5 cm STANDARD_DEVIATION 6.8	168.9 cm STANDARD_DEVIATION 6.8	172.5 cm STANDARD_DEVIATION 7.7
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	15 Participants	15 Participants	15 Participants	14 Participants	15 Participants	14 Participants	88 Participants
Region of Enrollment Russia	15 participants	15 participants	15 participants	15 participants	15 participants	15 participants	90 participants
Sex: Female, Male Female	4 Participants	8 Participants	4 Participants	3 Participants	4 Participants	10 Participants	33 Participants
Sex: Female, Male Male	11 Participants	7 Participants	11 Participants	12 Participants	11 Participants	5 Participants	57 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 15	0 / 15	0 / 15	0 / 15	0 / 15	0 / 15
other Total, other adverse events	13 / 15	14 / 15	14 / 15	15 / 15	15 / 15	15 / 15
serious Total, serious adverse events	0 / 15	1 / 15	0 / 15	0 / 15	0 / 15	0 / 15

Outcome results

Primary

Percentage of Patients With Negative HDV RNA by PCR

Negativation of HDV RNA by PCR (undetectable HDV RNA) at Week 72 (end of follow-up period)

Time frame: 72 weeks

Population: FAS

Arm	Measure	Value (NUMBER)
Arm A	Percentage of Patients With Negative HDV RNA by PCR	0 Percentage of participants
Arm B	Percentage of Patients With Negative HDV RNA by PCR	53.3 Percentage of participants
Arm C	Percentage of Patients With Negative HDV RNA by PCR	26.7 Percentage of participants
Arm D	Percentage of Patients With Negative HDV RNA by PCR	6.7 Percentage of participants
Arm E	Percentage of Patients With Negative HDV RNA by PCR	6.7 Percentage of participants
Arm F	Percentage of Patients With Negative HDV RNA by PCR	33.3 Percentage of participants

Comparison: The proportions of negative HDV RNA response at week 72 in each of the MXB treatment groups were compared with the control group of PEG-IFNα by using Fisher's exact test and by presenting exact unconditional 95%-confidence intervals (CI) based on scores for the proportion differences.p-value: 0.0022Fisher Exact

p-value: 0.0996Fisher Exact

p-value: 1Fisher Exact

p-value: 0.0421Fisher Exact

Secondary

Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).

Molecular analyses of relative HDV RNA expression, relative HBV pregenomic expression, relative total HBV RNA expression (X region), relative HBV RNA expression (S region) from baseline to post-treatment. \*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.

Time frame: 48 and 72 weeks

Population: FAS

Arm	Measure	Group	Value (MEAN)	Dispersion
Arm A	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative total HBV RNA expression (X region)	0.080 Relative value	Standard Deviation 1.07
Arm A	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HBV pregenomic expression	-0.028 Relative value	Standard Deviation 0.044
Arm A	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HBV RNA expression (S region)	-0.688 Relative value	Standard Deviation 1.977
Arm A	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HDV RNA expression	-0.062 Relative value	Standard Deviation 0.097
Arm B	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative total HBV RNA expression (X region)	-1.088 Relative value	Standard Deviation 1.624
Arm B	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HDV RNA expression	-0.068 Relative value	Standard Deviation 0.145
Arm B	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HBV pregenomic expression	-0.004 Relative value	Standard Deviation 0.007
Arm B	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HBV RNA expression (S region)	-2.295 Relative value	Standard Deviation 2.306
Arm C	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HBV RNA expression (S region)	-1.696 Relative value	Standard Deviation 1.423
Arm C	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative total HBV RNA expression (X region)	-1.295 Relative value	Standard Deviation 0.511
Arm C	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HDV RNA expression	0.296 Relative value	Standard Deviation 0.652
Arm C	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HBV pregenomic expression	0.003 Relative value	Standard Deviation 0.01
Arm D	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative total HBV RNA expression (X region)	-0.282 Relative value	Standard Deviation 0.796
Arm D	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HDV RNA expression	-1.220 Relative value	Standard Deviation 1.285
Arm D	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HBV RNA expression (S region)	-0.451 Relative value	Standard Deviation 0.962
Arm D	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HBV pregenomic expression	-0.001 Relative value	Standard Deviation 0.006
Arm E	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HBV RNA expression (S region)	0.223 Relative value	Standard Deviation 1.909
Arm E	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HDV RNA expression	-1.676 Relative value	Standard Deviation 2.754
Arm E	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HBV pregenomic expression	-0.041 Relative value	Standard Deviation 0.101
Arm E	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative total HBV RNA expression (X region)	0.160 Relative value	Standard Deviation 1.38
Arm F	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HBV RNA expression (S region)	0.733 Relative value	Standard Deviation 2.372
Arm F	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HBV pregenomic expression	0.049 Relative value	Standard Deviation 0.257
Arm F	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative total HBV RNA expression (X region)	0.403 Relative value	Standard Deviation 1.477
Arm F	Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).	Relative HDV RNA expression	-0.975 Relative value	Standard Deviation 1.732

Secondary

Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.

Molecular analyses of total HBV DNA (X region) copies/cell, HBV DNA (S region) copies/cell, cccDNA copies/cell from baseline to post-treatment. \*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.

Time frame: 48 and 72 weeks

Population: FAS

Arm	Measure	Group	Value (MEAN)	Dispersion
Arm A	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	HBV DNA (S region) copies/cell	-0.413 Copies/cell	Standard Deviation 0.784
Arm A	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	Total HBV DNA (X region) copies/cell	-0.041 Copies/cell	Standard Deviation 0.215
Arm A	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	cccDNA copies/cell	-0.045 Copies/cell	Standard Deviation 0.083
Arm B	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	HBV DNA (S region) copies/cell	-0.944 Copies/cell	Standard Deviation 1.265
Arm B	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	Total HBV DNA (X region) copies/cell	-0.027 Copies/cell	Standard Deviation 0.452
Arm B	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	cccDNA copies/cell	0.030 Copies/cell	Standard Deviation 0.05
Arm C	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	HBV DNA (S region) copies/cell	-0.747 Copies/cell	Standard Deviation 1.149
Arm C	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	Total HBV DNA (X region) copies/cell	-0.132 Copies/cell	Standard Deviation 0.223
Arm C	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	cccDNA copies/cell	0.004 Copies/cell	Standard Deviation 0.042
Arm D	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	HBV DNA (S region) copies/cell	0.124 Copies/cell	Standard Deviation 0.954
Arm D	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	Total HBV DNA (X region) copies/cell	0.036 Copies/cell	Standard Deviation 0.24
Arm D	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	cccDNA copies/cell	-0.003 Copies/cell	Standard Deviation 0.2
Arm E	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	HBV DNA (S region) copies/cell	-1.545 Copies/cell	Standard Deviation 3.047
Arm E	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	Total HBV DNA (X region) copies/cell	-0.297 Copies/cell	Standard Deviation 0.874
Arm E	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	cccDNA copies/cell	-0.117 Copies/cell	Standard Deviation 0.194
Arm F	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	Total HBV DNA (X region) copies/cell	0.087 Copies/cell	Standard Deviation 0.156
Arm F	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	cccDNA copies/cell	0.058 Copies/cell	Standard Deviation 0.165
Arm F	Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.	HBV DNA (S region) copies/cell	0.196 Copies/cell	Standard Deviation 0.517

Secondary

Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment

Molecular analysis of HDAg positive Hepatocytes (percentage of HDAg positive Hepatocytes) from baseline to post-treatment. \*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.

Time frame: 48 and 72 weeks

Population: FAS

Arm	Measure	Group	Value (MEAN)	Dispersion
Arm A	Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment	Baseline	0.757 Percentage	Standard Deviation 0.873
Arm A	Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment	Change from baseline to post-treatment	0.099 Percentage	—
Arm B	Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment	Change from baseline to post-treatment	-1.961 Percentage	Standard Deviation 3.439
Arm B	Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment	Baseline	2.178 Percentage	Standard Deviation 3.275
Arm C	Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment	Baseline	1.209 Percentage	Standard Deviation 1.001
Arm C	Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment	Change from baseline to post-treatment	-1.134 Percentage	Standard Deviation 0.995
Arm D	Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment	Change from baseline to post-treatment	-10.334 Percentage	Standard Deviation 9.041
Arm D	Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment	Baseline	7.550 Percentage	Standard Deviation 7.905
Arm E	Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment	Change from baseline to post-treatment	-9.028 Percentage	Standard Deviation 16.1
Arm E	Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment	Baseline	12.521 Percentage	Standard Deviation 13.855
Arm F	Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment	Baseline	3.641 Percentage	Standard Deviation 5.919
Arm F	Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment	Change from baseline to post-treatment	-3.616 Percentage	Standard Deviation 5.923

Secondary

Change in the Gene Expression Analyses From Baseline to Post-treatment

Change in the gene expression analyses of CXCL10, NTCP, CYP7A1, ISG15, MX1, OAS, HLA-E, TAP1 and USP18 from baseline to post-treatment. Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN.

Time frame: Weeks 48 - 72

Population: FAS

Arm	Measure	Group	Value (MEAN)	Dispersion
Arm A	Change in the Gene Expression Analyses From Baseline to Post-treatment	TAP1 relative expression	0.000 Relative value	Standard Deviation 0.007
Arm A	Change in the Gene Expression Analyses From Baseline to Post-treatment	USP18 relative expression	0.021 Relative value	Standard Deviation 0.017
Arm A	Change in the Gene Expression Analyses From Baseline to Post-treatment	CYP7A1 relative expression	0.002 Relative value	Standard Deviation 0.006
Arm A	Change in the Gene Expression Analyses From Baseline to Post-treatment	OAS relative expression	0.067 Relative value	Standard Deviation 0.059
Arm A	Change in the Gene Expression Analyses From Baseline to Post-treatment	HLA-E relative expression	0.038 Relative value	Standard Deviation 0.095
Arm A	Change in the Gene Expression Analyses From Baseline to Post-treatment	MX1 relative expression	0.175 Relative value	Standard Deviation 0.141
Arm A	Change in the Gene Expression Analyses From Baseline to Post-treatment	NTCP relative expression	0.001 Relative value	Standard Deviation 0.01
Arm A	Change in the Gene Expression Analyses From Baseline to Post-treatment	CXCL10 relative expression	-0.017 Relative value	Standard Deviation 0.033
Arm A	Change in the Gene Expression Analyses From Baseline to Post-treatment	ISG15 relative expression	0.207 Relative value	Standard Deviation 0.16
Arm B	Change in the Gene Expression Analyses From Baseline to Post-treatment	USP18 relative expression	-0.003 Relative value	Standard Deviation 0.016
Arm B	Change in the Gene Expression Analyses From Baseline to Post-treatment	OAS relative expression	-0.019 Relative value	Standard Deviation 0.063
Arm B	Change in the Gene Expression Analyses From Baseline to Post-treatment	NTCP relative expression	-0.016 Relative value	Standard Deviation 0.012
Arm B	Change in the Gene Expression Analyses From Baseline to Post-treatment	CYP7A1 relative expression	0.002 Relative value	Standard Deviation 0.006
Arm B	Change in the Gene Expression Analyses From Baseline to Post-treatment	CXCL10 relative expression	-0.012 Relative value	Standard Deviation 0.019
Arm B	Change in the Gene Expression Analyses From Baseline to Post-treatment	TAP1 relative expression	-0.012 Relative value	Standard Deviation 0.008
Arm B	Change in the Gene Expression Analyses From Baseline to Post-treatment	ISG15 relative expression	-0.092 Relative value	Standard Deviation 0.321
Arm B	Change in the Gene Expression Analyses From Baseline to Post-treatment	HLA-E relative expression	-0.322 Relative value	Standard Deviation 0.175
Arm B	Change in the Gene Expression Analyses From Baseline to Post-treatment	MX1 relative expression	-0.020 Relative value	Standard Deviation 0.186
Arm C	Change in the Gene Expression Analyses From Baseline to Post-treatment	NTCP relative expression	0.001 Relative value	Standard Deviation 0.004
Arm C	Change in the Gene Expression Analyses From Baseline to Post-treatment	OAS relative expression	0.005 Relative value	Standard Deviation 0.009
Arm C	Change in the Gene Expression Analyses From Baseline to Post-treatment	ISG15 relative expression	-0.003 Relative value	Standard Deviation 0.004
Arm C	Change in the Gene Expression Analyses From Baseline to Post-treatment	TAP1 relative expression	-0.001 Relative value	Standard Deviation 0.004
Arm C	Change in the Gene Expression Analyses From Baseline to Post-treatment	USP18 relative expression	-0.003 Relative value	Standard Deviation 0.006
Arm C	Change in the Gene Expression Analyses From Baseline to Post-treatment	CYP7A1 relative expression	0.000 Relative value	Standard Deviation 0.001
Arm C	Change in the Gene Expression Analyses From Baseline to Post-treatment	HLA-E relative expression	0.015 Relative value	Standard Deviation 0.179
Arm C	Change in the Gene Expression Analyses From Baseline to Post-treatment	MX1 relative expression	-0.013 Relative value	Standard Deviation 0.014
Arm C	Change in the Gene Expression Analyses From Baseline to Post-treatment	CXCL10 relative expression	0.010 Relative value	Standard Deviation 0.005
Arm D	Change in the Gene Expression Analyses From Baseline to Post-treatment	OAS relative expression	-0.015 Relative value	Standard Deviation 0.01
Arm D	Change in the Gene Expression Analyses From Baseline to Post-treatment	CXCL10 relative expression	-0.034 Relative value	Standard Deviation 0.009
Arm D	Change in the Gene Expression Analyses From Baseline to Post-treatment	NTCP relative expression	0.002 Relative value	Standard Deviation 0.005
Arm D	Change in the Gene Expression Analyses From Baseline to Post-treatment	CYP7A1 relative expression	0.001 Relative value	Standard Deviation 0.002
Arm D	Change in the Gene Expression Analyses From Baseline to Post-treatment	ISG15 relative expression	-0.037 Relative value	Standard Deviation 0.024
Arm D	Change in the Gene Expression Analyses From Baseline to Post-treatment	MX1 relative expression	-0.034 Relative value	Standard Deviation 0.019
Arm D	Change in the Gene Expression Analyses From Baseline to Post-treatment	HLA-E relative expression	-0.386 Relative value	Standard Deviation 0.197
Arm D	Change in the Gene Expression Analyses From Baseline to Post-treatment	TAP1 relative expression	-0.017 Relative value	Standard Deviation 0.009
Arm D	Change in the Gene Expression Analyses From Baseline to Post-treatment	USP18 relative expression	-0.005 Relative value	Standard Deviation 0.004
Arm E	Change in the Gene Expression Analyses From Baseline to Post-treatment	MX1 relative expression	-0.056 Relative value	Standard Deviation 0.122
Arm E	Change in the Gene Expression Analyses From Baseline to Post-treatment	ISG15 relative expression	-0.163 Relative value	Standard Deviation 0.286
Arm E	Change in the Gene Expression Analyses From Baseline to Post-treatment	HLA-E relative expression	0.149 Relative value	Standard Deviation 0.308
Arm E	Change in the Gene Expression Analyses From Baseline to Post-treatment	CYP7A1 relative expression	-0.001 Relative value	Standard Deviation 0.002
Arm E	Change in the Gene Expression Analyses From Baseline to Post-treatment	USP18 relative expression	-0.002 Relative value	Standard Deviation 0.012
Arm E	Change in the Gene Expression Analyses From Baseline to Post-treatment	TAP1 relative expression	0.007 Relative value	Standard Deviation 0.019
Arm E	Change in the Gene Expression Analyses From Baseline to Post-treatment	NTCP relative expression	0.011 Relative value	Standard Deviation 0.008
Arm E	Change in the Gene Expression Analyses From Baseline to Post-treatment	CXCL10 relative expression	0.003 Relative value	Standard Deviation 0.062
Arm E	Change in the Gene Expression Analyses From Baseline to Post-treatment	OAS relative expression	-0.025 Relative value	Standard Deviation 0.049
Arm F	Change in the Gene Expression Analyses From Baseline to Post-treatment	CXCL10 relative expression	-0.015 Relative value	Standard Deviation 0.017
Arm F	Change in the Gene Expression Analyses From Baseline to Post-treatment	ISG15 relative expression	-0.005 Relative value	Standard Deviation 0.034
Arm F	Change in the Gene Expression Analyses From Baseline to Post-treatment	OAS relative expression	0.003 Relative value	Standard Deviation 0.014
Arm F	Change in the Gene Expression Analyses From Baseline to Post-treatment	USP18 relative expression	0.001 Relative value	Standard Deviation 0.003
Arm F	Change in the Gene Expression Analyses From Baseline to Post-treatment	TAP1 relative expression	-0.004 Relative value	Standard Deviation 0.007
Arm F	Change in the Gene Expression Analyses From Baseline to Post-treatment	HLA-E relative expression	-0.061 Relative value	Standard Deviation 0.191
Arm F	Change in the Gene Expression Analyses From Baseline to Post-treatment	CYP7A1 relative expression	0.001 Relative value	Standard Deviation 0.003
Arm F	Change in the Gene Expression Analyses From Baseline to Post-treatment	MX1 relative expression	-0.000 Relative value	Standard Deviation 0.026
Arm F	Change in the Gene Expression Analyses From Baseline to Post-treatment	NTCP relative expression	0.004 Relative value	Standard Deviation 0.008

Secondary

Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment

Change (improvement/ worsening) in fibrosis and histological activity stage according to the liver biopsy study results from baseline to post-treatment Liver fibrosis was evaluated by histological staging systems with stage 0 corresponding to absence of fibrosis and with the highest score (the last stage in all systems) corresponding to cirrhosis. Improvement is defined as a decrease of at least 1 point in histological staging systems; worsening is defined as an increase of at least 1 point. Data should be interpreted with caution due to low number of paired biopsies available.

Time frame: 72 weeks

Population: FAS

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	Worsening	2 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	Improvement	0 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	Improvement	0 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	Improvement	2 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	No change	2 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	Worsening	1 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	Worsening	2 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	No change	2 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	Worsening	2 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	No change	2 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	Improvement	1 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	Improvement	0 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	No change	2 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	Worsening	2 Participants
Arm A	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	No change	0 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	Worsening	4 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	Worsening	3 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	Improvement	0 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	No change	0 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	No change	0 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	Improvement	1 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	Improvement	1 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	Worsening	4 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	Improvement	0 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	Worsening	2 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	Worsening	3 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	Improvement	0 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	No change	0 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	No change	1 Participants
Arm B	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	No change	1 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	Worsening	0 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	Worsening	0 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	Worsening	0 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	Improvement	2 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	Improvement	1 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	No change	3 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	Worsening	0 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	No change	2 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	Improvement	1 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	No change	3 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	No change	3 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	Worsening	0 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	No change	2 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	Improvement	2 Participants
Arm C	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	Improvement	1 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	No change	1 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	Worsening	0 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	Improvement	3 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	No change	1 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	Worsening	1 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	No change	2 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	Improvement	6 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	Improvement	4 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	Worsening	1 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	Improvement	4 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	Worsening	2 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	No change	2 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	Worsening	0 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	No change	2 Participants
Arm D	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	Improvement	6 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	No change	3 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	Improvement	3 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	No change	1 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	Worsening	1 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	Improvement	1 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	No change	3 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	Worsening	1 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	Improvement	1 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	No change	3 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	Worsening	1 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	Improvement	1 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	Worsening	1 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	Improvement	2 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	No change	1 Participants
Arm E	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	Worsening	2 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	No change	5 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	Improvement	8 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	Worsening	4 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	No change	3 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	No change	2 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	No change	1 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir fibrosis stage	Improvement	7 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	Worsening	4 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	No change	3 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Knodell fibrosis score	Improvement	7 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	Improvement	8 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	Worsening	4 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Metavir activity grade	Worsening	1 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Ishak fibrosis score	Worsening	4 Participants
Arm F	Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment	Histological activity index	Improvement	9 Participants

Secondary

Percentage of Patients With Combined Response

Combined response is defined as negative HDV RNA and ALT normalization at Weeks 24, 48, and 72. The criteria for combined response were HDV RNA value below LLoD (where LLoD=10 IU/ml) and ALT within normal range (≤31 U/L for females and ≤41 U/L for males)

Time frame: 24, 48 and 72 weeks

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Arm A	Percentage of Patients With Combined Response	Week 48	6.7 Percentage of participants
Arm A	Percentage of Patients With Combined Response	Week 24	0 Percentage of participants
Arm A	Percentage of Patients With Combined Response	Week 72	0 Percentage of participants
Arm B	Percentage of Patients With Combined Response	Week 48	20.0 Percentage of participants
Arm B	Percentage of Patients With Combined Response	Week 24	6.7 Percentage of participants
Arm B	Percentage of Patients With Combined Response	Week 72	46.7 Percentage of participants
Arm C	Percentage of Patients With Combined Response	Week 48	33.3 Percentage of participants
Arm C	Percentage of Patients With Combined Response	Week 24	20.0 Percentage of participants
Arm C	Percentage of Patients With Combined Response	Week 72	13.3 Percentage of participants
Arm D	Percentage of Patients With Combined Response	Week 48	13.3 Percentage of participants
Arm D	Percentage of Patients With Combined Response	Week 24	13.3 Percentage of participants
Arm D	Percentage of Patients With Combined Response	Week 72	6.7 Percentage of participants
Arm E	Percentage of Patients With Combined Response	Week 48	20.0 Percentage of participants
Arm E	Percentage of Patients With Combined Response	Week 24	13.3 Percentage of participants
Arm E	Percentage of Patients With Combined Response	Week 72	6.7 Percentage of participants
Arm F	Percentage of Patients With Combined Response	Week 24	13.3 Percentage of participants
Arm F	Percentage of Patients With Combined Response	Week 72	13.3 Percentage of participants
Arm F	Percentage of Patients With Combined Response	Week 48	13.3 Percentage of participants

Comparison: Week 24p-value: 1Fisher Exact

Comparison: Week 24p-value: 0.2241Fisher Exact

Comparison: Week 24p-value: 0.4828Fisher Exact

Comparison: Week 48p-value: 0.5977Fisher Exact

Comparison: Week 48p-value: 0.1686Fisher Exact

Comparison: Week 48p-value: 1Fisher Exact

Comparison: Week 48p-value: 0.5977Fisher Exact

Comparison: Week 48p-value: 1Fisher Exact

Comparison: Week 72p-value: 0.0063Fisher Exact

Comparison: Week 72p-value: 0.4828Fisher Exact

Comparison: Week 72p-value: 1Fisher Exact

Comparison: Week 72p-value: 0.4828Fisher Exact

Secondary

Percentage of Patients With HBsAg Negativation

Undetectable HВsAg with appearance of HbsAg antibodies or without it.

Time frame: 48 and 72 weeks

Population: According to SAP Section 7.1.5 - Handling of missing data.

Arm	Measure	Group	Value (NUMBER)
Arm A	Percentage of Patients With HBsAg Negativation	Week 48 HBsAg negativation with appearance of HbsAg antibodies	0 Percentage of participants
Arm A	Percentage of Patients With HBsAg Negativation	Week 72 HBsAg negativation with appearance of HbsAg antibodies	0 Percentage of participants
Arm A	Percentage of Patients With HBsAg Negativation	Week 48 HBsAg negativation without appearance of HbsAg antibodies	0 Percentage of participants
Arm A	Percentage of Patients With HBsAg Negativation	Week 72 HBsAg negativation without appearance of HbsAg antibodies	0 Percentage of participants
Arm B	Percentage of Patients With HBsAg Negativation	Week 48 HBsAg negativation without appearance of HbsAg antibodies	6.7 Percentage of participants
Arm B	Percentage of Patients With HBsAg Negativation	Week 72 HBsAg negativation with appearance of HbsAg antibodies	23.1 Percentage of participants
Arm B	Percentage of Patients With HBsAg Negativation	Week 48 HBsAg negativation with appearance of HbsAg antibodies	13.3 Percentage of participants
Arm B	Percentage of Patients With HBsAg Negativation	Week 72 HBsAg negativation without appearance of HbsAg antibodies	7.7 Percentage of participants
Arm C	Percentage of Patients With HBsAg Negativation	Week 72 HBsAg negativation without appearance of HbsAg antibodies	0 Percentage of participants
Arm C	Percentage of Patients With HBsAg Negativation	Week 48 HBsAg negativation without appearance of HbsAg antibodies	0 Percentage of participants
Arm C	Percentage of Patients With HBsAg Negativation	Week 72 HBsAg negativation with appearance of HbsAg antibodies	0 Percentage of participants
Arm C	Percentage of Patients With HBsAg Negativation	Week 48 HBsAg negativation with appearance of HbsAg antibodies	0 Percentage of participants
Arm D	Percentage of Patients With HBsAg Negativation	Week 48 HBsAg negativation with appearance of HbsAg antibodies	0 Percentage of participants
Arm D	Percentage of Patients With HBsAg Negativation	Week 72 HBsAg negativation without appearance of HbsAg antibodies	0 Percentage of participants
Arm D	Percentage of Patients With HBsAg Negativation	Week 72 HBsAg negativation with appearance of HbsAg antibodies	0 Percentage of participants
Arm D	Percentage of Patients With HBsAg Negativation	Week 48 HBsAg negativation without appearance of HbsAg antibodies	0 Percentage of participants
Arm E	Percentage of Patients With HBsAg Negativation	Week 48 HBsAg negativation without appearance of HbsAg antibodies	0 Percentage of participants
Arm E	Percentage of Patients With HBsAg Negativation	Week 72 HBsAg negativation without appearance of HbsAg antibodies	0 Percentage of participants
Arm E	Percentage of Patients With HBsAg Negativation	Week 72 HBsAg negativation with appearance of HbsAg antibodies	7.1 Percentage of participants
Arm E	Percentage of Patients With HBsAg Negativation	Week 48 HBsAg negativation with appearance of HbsAg antibodies	6.7 Percentage of participants
Arm F	Percentage of Patients With HBsAg Negativation	Week 72 HBsAg negativation with appearance of HbsAg antibodies	0 Percentage of participants
Arm F	Percentage of Patients With HBsAg Negativation	Week 48 HBsAg negativation without appearance of HbsAg antibodies	0 Percentage of participants
Arm F	Percentage of Patients With HBsAg Negativation	Week 72 HBsAg negativation without appearance of HbsAg antibodies	0 Percentage of participants
Arm F	Percentage of Patients With HBsAg Negativation	Week 48 HBsAg negativation with appearance of HbsAg antibodies	0 Percentage of participants

Comparison: Week 48p-value: 0.4828Fisher Exact

Comparison: Week 48p-value: 1Fisher Exact

Comparison: Week 72p-value: 0.2292Fisher Exact

Comparison: Week 72p-value: 1Fisher Exact

Secondary

Percentage of Patients With HВsAg Response

HВsAg response was defined as HBsAg negativation or \> 1 log10 IU/mL decline from baseline.

Time frame: 24, 48 and 72 weeks

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Arm A	Percentage of Patients With HВsAg Response	Week 48	0 Percentage of participants
Arm A	Percentage of Patients With HВsAg Response	Week 24	6.7 Percentage of participants
Arm A	Percentage of Patients With HВsAg Response	Week 72	0 Percentage of participants
Arm B	Percentage of Patients With HВsAg Response	Week 48	46.7 Percentage of participants
Arm B	Percentage of Patients With HВsAg Response	Week 24	40.0 Percentage of participants
Arm B	Percentage of Patients With HВsAg Response	Week 72	40.0 Percentage of participants
Arm C	Percentage of Patients With HВsAg Response	Week 48	20.0 Percentage of participants
Arm C	Percentage of Patients With HВsAg Response	Week 24	13.3 Percentage of participants
Arm C	Percentage of Patients With HВsAg Response	Week 72	13.3 Percentage of participants
Arm D	Percentage of Patients With HВsAg Response	Week 48	0 Percentage of participants
Arm D	Percentage of Patients With HВsAg Response	Week 24	0 Percentage of participants
Arm D	Percentage of Patients With HВsAg Response	Week 72	0 Percentage of participants
Arm E	Percentage of Patients With HВsAg Response	Week 48	6.7 Percentage of participants
Arm E	Percentage of Patients With HВsAg Response	Week 24	6.7 Percentage of participants
Arm E	Percentage of Patients With HВsAg Response	Week 72	13.3 Percentage of participants
Arm F	Percentage of Patients With HВsAg Response	Week 24	6.7 Percentage of participants
Arm F	Percentage of Patients With HВsAg Response	Week 72	0 Percentage of participants
Arm F	Percentage of Patients With HВsAg Response	Week 48	0 Percentage of participants

Comparison: Week 24p-value: 0.0801Fisher Exact

Comparison: Week 24p-value: 1Fisher Exact

Comparison: Week 48p-value: 0.0063Fisher Exact

Comparison: Week 48p-value: 0.2241Fisher Exact

Comparison: Week 48p-value: 1Fisher Exact

Comparison: Week 72p-value: 0.0169Regression, Cox

Comparison: Week 72p-value: 0.4828Fisher Exact

Secondary

Percentage of Patients With Negative HBV DNA by PCR

Percentage of patients with undetectable HBV DNA by PCR at Weeks 24, 48 and 72

Time frame: 24, 48 and 72 weeks

Arm	Measure	Group	Value (NUMBER)
Arm A	Percentage of Patients With Negative HBV DNA by PCR	Week 48	26.7 Percentage of participants
Arm A	Percentage of Patients With Negative HBV DNA by PCR	Week 24	33.3 Percentage of participants
Arm A	Percentage of Patients With Negative HBV DNA by PCR	Week 72	33.3 Percentage of participants
Arm B	Percentage of Patients With Negative HBV DNA by PCR	Week 48	73.3 Percentage of participants
Arm B	Percentage of Patients With Negative HBV DNA by PCR	Week 24	53.3 Percentage of participants
Arm B	Percentage of Patients With Negative HBV DNA by PCR	Week 72	66.7 Percentage of participants
Arm C	Percentage of Patients With Negative HBV DNA by PCR	Week 48	40.0 Percentage of participants
Arm C	Percentage of Patients With Negative HBV DNA by PCR	Week 24	40.0 Percentage of participants
Arm C	Percentage of Patients With Negative HBV DNA by PCR	Week 72	40.0 Percentage of participants
Arm D	Percentage of Patients With Negative HBV DNA by PCR	Week 48	33.3 Percentage of participants
Arm D	Percentage of Patients With Negative HBV DNA by PCR	Week 24	33.3 Percentage of participants
Arm D	Percentage of Patients With Negative HBV DNA by PCR	Week 72	40.0 Percentage of participants
Arm E	Percentage of Patients With Negative HBV DNA by PCR	Week 48	66.7 Percentage of participants
Arm E	Percentage of Patients With Negative HBV DNA by PCR	Week 24	53.3 Percentage of participants
Arm E	Percentage of Patients With Negative HBV DNA by PCR	Week 72	26.7 Percentage of participants
Arm F	Percentage of Patients With Negative HBV DNA by PCR	Week 24	80.0 Percentage of participants
Arm F	Percentage of Patients With Negative HBV DNA by PCR	Week 72	46.7 Percentage of participants
Arm F	Percentage of Patients With Negative HBV DNA by PCR	Week 48	93.3 Percentage of participants

Comparison: Week 24p-value: 0.4621Fisher Exact

Comparison: Week 24p-value: 1Chi-squared, Corrected

Comparison: Week 24p-value: 1Fisher Exact

Comparison: Week 24p-value: 0.4621Fisher Exact

Comparison: Week 24p-value: 0.0253Fisher Exact

Comparison: Week 48p-value: 0.0268Fisher Exact

Comparison: Week 48p-value: 0.6999Fisher Exact

Comparison: Week 48p-value: 1Fisher Exact

Comparison: Week 48p-value: 0.0656Fisher Exact

Comparison: Week 48p-value: 0.0005Fisher Exact

Comparison: Week 72p-value: 0.1431Fisher Exact

Comparison: Week 72p-value: 1Fisher Exact

Comparison: Week 72p-value: 0.7104Fisher Exact

Secondary

Percentage of Patients With Negative HDV RNA by PCR

Percentage of patients with negative HDV RNA by PCR (undetectable HDV RNA) at Weeks 24 and 48

Time frame: 24 and 48 weeks

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Arm A	Percentage of Patients With Negative HDV RNA by PCR	Week 24	6.7 Percentage of participants
Arm A	Percentage of Patients With Negative HDV RNA by PCR	Week 48	13.3 Percentage of participants
Arm B	Percentage of Patients With Negative HDV RNA by PCR	Week 24	60.0 Percentage of participants
Arm B	Percentage of Patients With Negative HDV RNA by PCR	Week 48	80.0 Percentage of participants
Arm C	Percentage of Patients With Negative HDV RNA by PCR	Week 24	60.0 Percentage of participants
Arm C	Percentage of Patients With Negative HDV RNA by PCR	Week 48	86.7 Percentage of participants
Arm D	Percentage of Patients With Negative HDV RNA by PCR	Week 24	13.3 Percentage of participants
Arm D	Percentage of Patients With Negative HDV RNA by PCR	Week 48	13.3 Percentage of participants
Arm E	Percentage of Patients With Negative HDV RNA by PCR	Week 24	66.7 Percentage of participants
Arm E	Percentage of Patients With Negative HDV RNA by PCR	Week 48	80 Percentage of participants
Arm F	Percentage of Patients With Negative HDV RNA by PCR	Week 24	26.7 Percentage of participants
Arm F	Percentage of Patients With Negative HDV RNA by PCR	Week 48	46.7 Percentage of participants

Comparison: Week 24p-value: 0.0052Fisher Exact

Comparison: Week 24p-value: 1Fisher Exact

Comparison: Week 24p-value: 0.0017Fisher Exact

Comparison: Week 24p-value: 0.3295Fisher Exact

Comparison: Week 48p-value: 0.0007Fisher Exact

Comparison: Week 48p-value: 0.0001Fisher Exact

Comparison: Week 48p-value: 1Fisher Exact

Comparison: Week 48p-value: 0.0007Fisher Exact

Comparison: Week 48p-value: 0.1086Fisher Exact

Secondary

Percentage of Patients With Normalized ALT

Percentage of patients with normalized ALT at Weeks 24, 48 and 72. ALT normalisation was defined as having an ALT value within the normal range (≤31 U/L for females and ≤41 U/L for males)

Time frame: 24, 48 and 72 weeks

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Arm A	Percentage of Patients With Normalized ALT	Week 48	26.7 Percentage of participants
Arm A	Percentage of Patients With Normalized ALT	Week 24	0 Percentage of participants
Arm A	Percentage of Patients With Normalized ALT	Week 72	10.0 Percentage of participants
Arm B	Percentage of Patients With Normalized ALT	Week 48	26.7 Percentage of participants
Arm B	Percentage of Patients With Normalized ALT	Week 24	6.7 Percentage of participants
Arm B	Percentage of Patients With Normalized ALT	Week 72	53.8 Percentage of participants
Arm C	Percentage of Patients With Normalized ALT	Week 72	33.3 Percentage of participants
Arm C	Percentage of Patients With Normalized ALT	Week 24	20.0 Percentage of participants
Arm C	Percentage of Patients With Normalized ALT	Week 48	46.7 Percentage of participants
Arm D	Percentage of Patients With Normalized ALT	Week 72	23.1 Percentage of participants
Arm D	Percentage of Patients With Normalized ALT	Week 48	73.3 Percentage of participants
Arm D	Percentage of Patients With Normalized ALT	Week 24	64.3 Percentage of participants
Arm E	Percentage of Patients With Normalized ALT	Week 72	35.7 Percentage of participants
Arm E	Percentage of Patients With Normalized ALT	Week 24	20.0 Percentage of participants
Arm E	Percentage of Patients With Normalized ALT	Week 48	26.7 Percentage of participants
Arm F	Percentage of Patients With Normalized ALT	Week 24	60.0 Percentage of participants
Arm F	Percentage of Patients With Normalized ALT	Week 72	35.7 Percentage of participants
Arm F	Percentage of Patients With Normalized ALT	Week 48	40.0 Percentage of participants

Comparison: Week 24p-value: 1Fisher Exact

Comparison: Week 24p-value: 0.2241Fisher Exact

Comparison: Week 24p-value: 0.0002Fisher Exact

Comparison: Week 24p-value: 0.2241Fisher Exact

Comparison: Week 24p-value: 0.0007Fisher Exact

Comparison: Week 48p-value: 1Fisher Exact

Comparison: Week 48p-value: 0.4497Fisher Exact

Comparison: Week 48p-value: 0.0268Fisher Exact

Comparison: Week 48p-value: 1Fisher Exact

Comparison: Week 48p-value: 0.6999Fisher Exact

Comparison: Week 72p-value: 0.0743Fisher Exact

Comparison: Week 72p-value: 0.3449t-test, 1 sided

Comparison: Week 72p-value: 0.6036Fisher Exact

Comparison: Week 72p-value: 0.3408Fisher Exact

Secondary

The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.

Change in liver stiffness and intensity of liver fibrosis based on results of transient elastometry of liver at weeks 48 and 72.

Time frame: 48 and 72 weeks

Population: FAS

Arm	Measure	Group	Value (MEAN)	Dispersion
Arm A	The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.	Change from baseline to Week 72	-0.67 kPa	Standard Deviation 5.25
Arm A	The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.	Change from baseline to Week 48	-0.67 kPa	Standard Deviation 2.78
Arm B	The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.	Change from baseline to Week 72	0.65 kPa	Standard Deviation 2.1
Arm B	The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.	Change from baseline to Week 48	1.97 kPa	Standard Deviation 3.94
Arm C	The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.	Change from baseline to Week 72	-2.06 kPa	Standard Deviation 4.49
Arm C	The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.	Change from baseline to Week 48	-0.27 kPa	Standard Deviation 3.83
Arm D	The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.	Change from baseline to Week 72	0.00 kPa	Standard Deviation 6.19
Arm D	The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.	Change from baseline to Week 48	-0.66 kPa	Standard Deviation 2.52
Arm E	The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.	Change from baseline to Week 72	0.21 kPa	Standard Deviation 6.53
Arm E	The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.	Change from baseline to Week 48	-2.35 kPa	Standard Deviation 7.47
Arm F	The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.	Change from baseline to Week 48	-1.12 kPa	Standard Deviation 3.23
Arm F	The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.	Change from baseline to Week 72	-1.20 kPa	Standard Deviation 2.68

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026

Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Patients With Negative HDV RNA by PCR

Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).

Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.

Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment

Change in the Gene Expression Analyses From Baseline to Post-treatment

Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment

Percentage of Patients With Combined Response

Percentage of Patients With HBsAg Negativation

Percentage of Patients With HВsAg Response

Percentage of Patients With Negative HBV DNA by PCR

Percentage of Patients With Negative HDV RNA by PCR

Percentage of Patients With Normalized ALT

The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.