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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00962871

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Tenofovir Peginterferon Alfa-2a Tenofovir Disoproxil Fumarate Recombinant Hepatitis B vaccine Hepatitis A Vaccines

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:	25
Study Start Date:	August 2009
Estimated Study Completion Date:	October 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

Grafton, 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:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00962871 History of Changes
Other Study ID Numbers:	PP22512
Study First Received:	August 19, 2009
Last Updated:	May 21, 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 23, 2012