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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B, Chronic

Intervention: peginterferon alfa-2a (40KD) [PEGASYS] (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Normalization of ALT, and HBV-DNA <10,000 copies/mL

Secondary outcome:

Normalization of ALT, and HBV-DNA <10,000 copies/mL

HBsAg loss and anti-HBs seroconversion

AEs and lab parameters

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Ankara 06620, Turkey

Antalya 07058, Turkey

Istanbul 34390, Turkey

Izmir 35360, Turkey

Additional Information

Starting date: September 2007
Last updated: June 27, 2008

Page last updated: August 23, 2015

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