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

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: Peginterferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT00436163

ML20601

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Peginterferon Alfa-2a

Experimental group

Description:

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

Treatment:

Drug: Peginterferon alfa-2a