A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)
NCT02604823 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 307
Last updated 2016-11-02
Summary
This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Conditions
- Hepatitis B, Chronic
Interventions
- DRUG
-
Peginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-11-30
- Primary Completion
- 2005-11-30
- Completion
- 2005-11-30
Countries
- China
Study Locations
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