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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 study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962871
First Posted: August 20, 2009
Last Update Posted: February 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Hepatitis B, Chronic Drug: peginterferon alfa-2a [Pegasys] Drug: tenofovir Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 30
Study Start Date: August 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: tenofovir
300mg po daily for 2 weeks
Experimental: 2 Drug: peginterferon alfa-2a [Pegasys]
360 micrograms sc/week for 2 weeks
Drug: tenofovir
300mg po daily for 2 weeks
Experimental: 3 Drug: peginterferon alfa-2a [Pegasys]
360 micrograms sc/week for 2 weeks
No Intervention: 4

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962871


Locations
United States, California
Los Angeles, California, United States, 90036
San Francisco, California, United States, 94143-0538
New Zealand
Grafton, New Zealand, 1010
Singapore
Singapore, Singapore, 119228
Singapore, Singapore, 169608
Taiwan
Taipei, Taiwan, 100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00962871     History of Changes
Other Study ID Numbers: PP22512
First Submitted: August 19, 2009
First Posted: August 20, 2009
Results First Submitted: December 9, 2015
Results First Posted: January 13, 2016
Last Update Posted: February 8, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Immunologic Factors
Physiological Effects of Drugs