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OpenTrials
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NCT Number: NCT00962871

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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Grafton, New Zealand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peginterferon alfa-2a [Pegasys]

Drug

360 micrograms sc/week for 2 weeks

Tenofovir

Drug

300mg po daily for 2 weeks

Primary outcomes

  1. Mean Change From Baseline in Viral Quantitative e Antibody

    Time frame: 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 outcomes

  1. Mean Change From Baseline in HBV-DNA log10

    Time frame: 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.

  2. Early Changes in Viral Sequence Associated With Viral Suppression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label, Randomized Study to Evaluate the Acute Immunologic Responses in Asian Subjects With E Antigen Positive Chronic Hepatitis B Following Initiation of Therapy for Hepatitis B With Pegasys, Nucleoside Analogues, or Both.

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 20, 2009
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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