A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
This study has been terminated.
(Low recruitment rate due to treatment regimen change)
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00460850
First received: April 16, 2007
Last updated: June 27, 2008
Last verified: June 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hepatitis B, Chronic |
Drug: peginterferon alfa-2a (40KD) [PEGASYS] |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Normalization of ALT, and HBV-DNA <10,000 copies/mL [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Normalization of ALT, and HBV-DNA <10,000 copies/mL [ Time Frame: Weeks 48 and 72 ] [ Designated as safety issue: No ]
- HBsAg loss and anti-HBs seroconversion [ Time Frame: Weeks 48, 72 and 96 ] [ Designated as safety issue: No ]
- AEs and lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2007 |
| Study Completion Date: | June 2008 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Clinical Trials, Study Director, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00460850 History of Changes |
| Other Study ID Numbers: | ML20135 |
| Study First Received: | April 16, 2007 |
| Last Updated: | June 27, 2008 |
| Health Authority: | Turkey: Ministry of Health General Management of Drugs and Pharmaceutics Ethics Committee. |
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 Lamivudine |
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 19, 2013