Trial Information

Summary: A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With HBeAg-Positive Chronic Hepatitis B (CHB).

Status: Recruiting

Protocol Number: ML20601

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open label study evaluating safety and the effect of PEGASYSŪ on HBV DNA levels in patients with HBeAg-positive and HBeAg-negative chronic hepatitis B

Brief Summary: This single arm study will evaluate the efficacy and safety of PEGASYS in treatment-naive Baltic patients with HBeAg-positive chronic HBV. All patients will receive PEGASYS 180 micrograms s.c. 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 <100 individuals. Target sample size is 50.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: Hepatitis B, Chronic

Intervention Type: Drug

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

Primary Outcome: 1. Number of patients with HBV DNA <100,000 copies/mL Time frame: Week 72

Key Secondary Outcomes: 1. HBV DNA <400 copies/mL, HBsAg seroconversion, ALT normalization, sustained HBe seroconversion. Time frame: Weeks 48 and 72 2. AEs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 70 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: March, 2007

Trial Registration Date: 02/16/2007

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: August 20, 2008 at 2:21:00 PM