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.
- Conditions
- Hepatitis B virus e-antigen (HBeAg)-negative subjects with chronic hepatitis B virus infection (CHB)MedDRA version: 20.1Level: LLTClassification code 10054283Term: HBV DNA detectableSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2017-001647-12-PL
- Lead Sponsor
- Arbutus Biopharma Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br><br>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)?<br>;Primary end point(s): Proportion of treated subjects with HBsAg decline =2 log10;Timepoint(s) of evaluation of this end point: Week 30
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Proportion of subjects who achieve HBsAg <LLOQ and who achieve HBV-DNA <LLOQ<br>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<br>2) Throughout course of study treatment up to 28 days after the last dose of study treatment.