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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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00962871
First received: August 19, 2009
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Acute immunologic response [ Time Frame: assessed days 1-14 and weekly during follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Early kinetics of viral suppression [ Time Frame: assessed days 1-14 and weekly during follow-up ] [ Designated as safety issue: No ]
  • Early changes in viral sequence associated with viral suppression [ Time Frame: assessed days 1, 14, 28 and 42 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: August 2009
Study Completion Date: August 2012
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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962871

Locations
United States, California
Los Angeles, California, United States, 90036
San Francisco, California, United States, 94143-0538
New Zealand
Auckland, New Zealand, 1150
Singapore
Singapore, Singapore, 169608
Singapore, Singapore, 119228
Taiwan
Taipei, Taiwan, 100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00962871     History of Changes
Other Study ID Numbers: PP22512
Study First Received: August 19, 2009
Last Updated: December 3, 2012
Health Authority: New Zealand: Health Research Council

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013