A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both

Phase 1

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: tenofovir; Drug: peginterferon alfa-2a [Pegasys]

• Registration Number: NCT00962871
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4 cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may opt to receive standard of care treatment with Pegasys. Target sample size is \<50.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-19
• Study First Posted: 2009-08-20
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2015-12-09
• Results First Submitted QC: 2015-12-09
• Status Verified: 2016-01
• Results First Posted: 2016-01-13
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• male adults of Southeast and/or East Asian origin, 18-55 years of age
• HBeAg-positive chronic hepatitis B
• detectable HBV DNA

Exclusion Criteria

• prior antiviral therapy for chronic hepatitis B
• evidence of bridging fibrosis, cirrhosis or decompensated liver disease
• positive test at screening for HAV (IgM), HCV, HDV or HIV
• history or evidence of medical condition associated with chronic liver disease
• antineoplastic or immunomodulatory treatment </=6 months prior to first dose of study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	tenofovir	-
2	peginterferon alfa-2a [Pegasys]	-
3	peginterferon alfa-2a [Pegasys]	-
2	tenofovir	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Viral Quantitative e Antibody	Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)	An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in HBV-DNA log10	Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)	An acute virologic response was determined by change from baseline in HBV-DNA log10.
Early Changes in Viral Sequence Associated With Viral Suppression	Day 1, 5, 14, Week 4 and 6	Viral sequence data was obtained from the first 10 participants enrolled in Study but on analysis of the data, numerous low frequency deviations from the HBV consensus sequences were observed in the 454 SLX sequence data which were not replicated in data obtained from routine Sanger sequencing. These sequence deviations did not correspond to a temporal pattern consistent with selection of mutations following HBV treatment. Moreover, they could not be reliably distinguished from sequencing artifacts. It was also revealed that complete genome coverage was not obtained due to errors in the design of the primer sequences. For these reasons, further sequence analyses were not performed for the remaining treatment population.