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

Roche

Status and phase: Terminated; Phase 4

Conditions: Hepatitis B, Chronic

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00460850

ML20135

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

1

Experimental group

Treatment:

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