To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy.

To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03123653

Enrollment

118

Registered

2017-04-21

Start date

2017-03-17

Completion date

2020-09-17

Last updated

2020-02-05

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

Conditions

Hepatitis B

Brief summary

* Study population:Person with HBeAg negative CHB on TDF/ETV for more than 1 year * Study design:Prospective,Interventional (single arm study) * Sample size: All the patients fulfilling the inclusion criteria will be included in first 6 months and subsequently followed up for 2 years * Intervention: Peg IFN 2b 1.5mcg/kg once every week for 48 weeks * Monitoring and assessment: LFT,HBV DNA and HbsAg at baseline, 4 weeks, 12 weeks,24 weeks,48 weeks ,72 weeks and 96 weeks, CBC every month and Thyroid function Test every 3rd month * Adverse effects: The most frequently reported side effects of IFN-based therapy are flu-like symptoms, headache, fatigue, myalgia, alopecia, and local reaction at the injection site. Peg-IFN have myelosuppressive effects; however, neutropenia\\1000/mm3 and thrombocytopenia \\500,000/ mm3 are not common unless patients already have cirrhosis

Interventions

DRUGPeg IFN 2b

Peg IFN 2b 1.5mcg/kg once every week for 48 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

\- HBeAg negative Chronic HBV infection who are having HBV DNA-undetectable. ALT \<40 IU/ml No Advanced fibrosis\[LSM \<14 KPa\] TDF/ETV \>1 year Clinical Relapse after stopping NA will be defined as HBV DNA\>2000IU/ml and ALT \> 80IU

Exclusion criteria

\- HBeAg+ CHB Pregnancy Cirrhosis on biopsy or LSM \>14 Co-infection- HIV/HCV/HDV Immunosuppressive therapy Renal failure S.Bilirubin\>2mg/dl Patient having neutropenia

Design outcomes

Primary

Measure	Time frame
Sustained Virological Response-HBV DNA<2000IU/ml after stopping PEG IFN alpha	6 months

Secondary

Measure	Time frame
Loss of HBsAg after 48 weeks of PEG IFN alpha	48 weeks
End treatment Response: HBV-DNA -undetectable after 48 weeks of PEG-IFN	48 weeks
Sustained Off treatment Virological response defined as No clinical relapse during 1 year follow up after stopping therapy	1 year

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026