A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-05-31

Brief Summary

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This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. Following 48 weeks of 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 less than 100 participants.

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Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peginterferon Alfa-2a

Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.

Group Type EXPERIMENTAL

Peginterferon alfa-2a

Intervention Type DRUG

180 mcg subcutaneously once per week for 48 weeks.

Interventions

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Peginterferon alfa-2a

180 mcg subcutaneously once per week for 48 weeks.

Intervention Type DRUG

Other Intervention Names

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Pegasys®

Eligibility Criteria

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Inclusion Criteria

* Adult participants, 18-70 years of age;
* HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal to 6 months;
* anti-HBs negative;
* Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000 copies/milliliters.

Exclusion Criteria

* Previous antiviral or interferon-based therapy for chronic hepatitis B;
* Evidence of decompensated liver disease;
* Chronic liver disease other than viral hepatitis;
* Co-infection with active hepatitis A, C or D virus;
* Co-infection with human immunodeficiency virus.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No