Trial Information

Summary: A Pilot Study of New-Onset Therapy With PEGASYS (Peginterferon alfa-2a (40KD)) in Pre-Treated Patients With Chronic Hepatitis B.

Status: Completed

Protocol Number: ML17619

Sponsor: F. Hoffmann-La Roche Ltd

Company Division: Pharmaceutical

Official Scientific Title: A randomised, open-label study to compare the effect of new-onset therapy with PEGASYS, and continuation therapy with adefovir dipivoxil or lamivudine, on viral response in patients with chronic hepatitis B pre-treated with adefovir dipivoxil or lamivudine.

Brief Summary: This study will compare the efficacy and safety of PEGASYS (180 micrograms sc weekly) and continued treatment with adefovir dipivoxil (10mg po, daily) or lamivudine (100mg po, daily) in patients with chronic hepatitis B (CHB) who have been pre-treated with adefovir dipivoxil or lamivudine for >6 months. Patients will be randomized to receive either PEGASYS for 48 weeks (first 4 weeks in addition to pre-existing adefovir dipivoxil or lamivudine) followed by a 24 week treatment-free period, or adefovir dipivoxil or lamivudine for 72 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is 140.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• 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. Loss of HBsAg at 72 weeks after start of randomized treatment.

Key Secondary Outcomes: 1. Efficacy: Loss of HBsAg at 48 weeks, HBV DNA BLQ at weeks 48 and 72, ALT at weeks 48 and 72. Safety: Adverse events, laboratory tests.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/16/2006

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:57:49 PM