A study to determine how safe the treatment is for subjects diagnosed with hepatitis B virus infections when combined with other treatments for hepatitis B. Subjects must have no evidence of liver damage.

A Phase 2a, Open-Label, Study Evaluating the Safety and Anti-Viral Activity of ARB-001467 in Non-Cirrhotic, HBeAg-Negative Subjects with Chronic HBV Infection (Genotype A or B) in Combination with PEG-IFN a-2a and Tenofovir Disoproxil Fumarate

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001647-12-PL

Enrollment

Registered

2018-02-01

Start date

2018-03-07

Completion date

Unknown

Last updated

2020-05-25

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

Conditions

Hepatitis B virus e-antigen (HBeAg)-negative subjects with chronic hepatitis B virus infection (CHB) MedDRA version: 20.1 Level: LLT Classification code 10054283 Term: HBV DNA detectable System Organ Class: 100000004848

Interventions

Product Name: ARB-001467 Product Code: ARB-001467 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Not assigned CAS Number: Not assigned Current Sponsor code: UsiHBV-1 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Chronic HBV infection as documented at screening by either: a. Positive HBsAg, or hepatitis B virus e-antigen (HBeAg; negative or positive) or HBV-DNA at least 6 months prior to screening; OR b. Historical liver biopsy consistent with chronic HBV infection with documentation available at screening 2. Subject must be HBV-DNA(+) with a HBV-DNA =1000 IU/mL and either treatment-naive or treatment-experienced, defined as follows: a. Treatment naïve subjects: Subjects have never received nucleos(t)ide analogue (NA) therapies including, but not limited to, TDF, entecavir, telbivudine, or lamivudine and/or interferon-alpha; OR b. Treatment experienced subjects: Subjects may have previously had NA therapies (including, but not limited to, TDF, entecavir, telbivudine, or lamivudine) and/or interferon-alfa therapy, but must have discontinued treatment at least 6 months prior to screening 3. Quantitative HBsAg =1000 IU/mL and =10000 IU/mL at the Screening Visit 4. HBV genotype A or B at the screening visit 5. Interleukin (IL)28B CC Genotype 6. HBeAg-negative at the screening visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Known co infection with any of the following: Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), Hepatitis D virus (HDV), or Hepatitis E virus (HEV). 2. Any known pre existing medical or psychiatric condition that could interfere with the subject’s ability to provide informed consent or participate in study conduct, or that may confound study findings.

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore the anti-viral efficacy of combination therapy with ARB-001467 plus TDF and PEG-IFN a-2a in subjects with chronic hepatitis B (CHB) due to HBV genotype A or B, who are HBV-DNA positive;Secondary Objective: To evaluate the proportion of subjects who achieve HBsAg <lower limit of quantification (LLOQ) and who achieve HBV-DNA <LLOQ throughout the study To evaluate on-treatment safety as measured by the frequency of adverse events (AEs), discontinuations due to AEs, and selected Grade 3-4 laboratory abnormalities (based on the Common Terminology Criteria for Adverse Events [CTCAE] criteria)? ;Primary end point(s): Proportion of treated subjects with HBsAg decline =2 log10;Timepoint(s) of evaluation of this end point: Week 30	—

Measure

Time frame

Main Objective: To explore the anti-viral efficacy of combination therapy with ARB-001467 plus TDF and PEG-IFN a-2a in subjects with chronic hepatitis B (CHB) due to HBV genotype A or B, who are HBV-DNA positive;Secondary Objective: To evaluate the proportion of subjects who achieve HBsAg <lower limit of quantification (LLOQ) and who achieve HBV-DNA <LLOQ throughout the study To evaluate on-treatment safety as measured by the frequency of adverse events (AEs), discontinuations due to AEs, and selected Grade 3-4 laboratory abnormalities (based on the Common Terminology Criteria for Adverse Events [CTCAE] criteria)? ;Primary end point(s): Proportion of treated subjects with HBsAg decline =2 log10;Timepoint(s) of evaluation of this end point: Week 30

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Secondary

Measure	Time frame
Secondary end point(s): 1) Proportion of subjects who achieve HBsAg <LLOQ and who achieve HBV-DNA <LLOQ 2)On-treatment safety as measured by frequency of AEs, discontinuations due to AEs, and selected Grade 3-4 laboratory abnormalities (including hematologic and liver function, based on CTCAE criteria);Timepoint(s) of evaluation of this end point: 1) Weeks: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28 and 30; and Post-treatment Weeks 4, 8, 12 and 24 2) Throughout course of study treatment up to 28 days after the last dose of study treatment.	—

Measure

Time frame

Secondary end point(s): 1) Proportion of subjects who achieve HBsAg <LLOQ and who achieve HBV-DNA <LLOQ 2)On-treatment safety as measured by frequency of AEs, discontinuations due to AEs, and selected Grade 3-4 laboratory abnormalities (including hematologic and liver function, based on CTCAE criteria);Timepoint(s) of evaluation of this end point: 1) Weeks: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28 and 30; and Post-treatment Weeks 4, 8, 12 and 24 2) Throughout course of study treatment up to 28 days after the last dose of study treatment.

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Countries

Poland, Spain, Taiwan

Contacts

Public ContactArbutus Regulatory Affairs

Arbutus Biopharma Corporation

regulatory@arbutusbio.com1267422-1348

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026