A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.

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. Identifier: NCT00460850
Recruitment Status : Terminated (Low recruitment rate due to treatment regimen change)
First Posted : April 17, 2007
Last Update Posted : June 30, 2008
Information provided by:
Hoffmann-La Roche

Brief Summary:
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: peginterferon alfa-2a (40KD) [PEGASYS] Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B
Study Start Date : September 2007
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks

Primary Outcome Measures :
  1. Normalization of ALT, and HBV-DNA <10,000 copies/mL [ Time Frame: Week 96 ]

Secondary Outcome Measures :
  1. Normalization of ALT, and HBV-DNA <10,000 copies/mL [ Time Frame: Weeks 48 and 72 ]
  2. HBsAg loss and anti-HBs seroconversion [ Time Frame: Weeks 48, 72 and 96 ]
  3. AEs and lab parameters [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-65 years of age;
  • HBeAg negative chronic hepatitis B;
  • treated with lamivudine for >=6 months;
  • demonstrated lamivudine resistance;
  • compensated liver disease.

Exclusion Criteria:

  • severe hepatic dysfunction;
  • previous treatment with antivirals other than lamivudine;
  • immunosuppressant treatment in past 6 months;
  • co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
  • medical condition associated with chronic liver disease.

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 identifier (NCT number): NCT00460850

Ankara, Turkey, 06620
Antalya, Turkey, 07058
Istanbul, Turkey, 34390
Izmir, Turkey, 35360
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche Identifier: NCT00460850     History of Changes
Other Study ID Numbers: ML20135
First Posted: April 17, 2007    Key Record Dates
Last Update Posted: June 30, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
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
Peginterferon alfa-2a
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Immunologic Factors
Physiological Effects of Drugs