Trial Information

Summary: A Study of PEGASYS (Peginterferon alfa-2a (40KD)) With or Without Ribavirin in Patients With Chronic Hepatitis D (CHD)

Status: No longer recruiting

Protocol Number: ML18149

Sponsor: Roche S.p.A.

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study to compare the effect of PEGASYS monotherapy and PEGASYS + ribavirin combination therapy on treatment response in patients with chronic hepatitis D.

Brief Summary: This study will compare the efficacy and safety of 48 weeks treatment with PEGASYS montherapy (180 micrograms sc weekly) or PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in patients with chronic hepatitis D. Virologic and biochemical response will be evaluated at the end of treatment, and after 12 months 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 24.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Hepatitis D, Chronic

Intervention Type: Drug

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

Primary Outcome: 1. End of treatment and long term response (normalization of serum transaminases, negative serum HDV RNA and complete response).

Key Secondary Outcomes: 1. Adverse events, laboratory parameters.

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: October, 2004

Trial Registration Date: 05/04/2006

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: July 7, 2008 at 3:09:34 PM