Trial Information

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

Status: Recruiting

Protocol Number: WV19432

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of treatment duration and dose of PEGASYS on HBeAg seroconversion and safety in patients with HBeAg positive chronic hepatitis B.

Brief Summary: This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms sc weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 528.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Hepatitis B, Chronic

Intervention Type: Drug

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

Primary Outcome: 1. HBeAg seroconversion Time frame: At end of initial 24 week treatment-free follow-up.

Key Secondary Outcomes: 1. Loss of ABeAg, HBsAg seroconversion, loss of HBsAg, ALT, HBV-DNA. Time frame: At end of 24 week treatment-free follow-up, and at week 72. 2. HBeAg seroconversion Time frame: Week 72 3. AEs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 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: September 2, 2008 at 2:13:52 PM