Trial Information

Summary: A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Chronic Hepatitis D (CHD)

Status: No longer recruiting

Protocol Number: ML18788

Sponsor: Roche Romania

Company Division: Pharmaceutical

Official Scientific Title: An open-label study to evaluate the effect of PEGASYSŪ (Peginterferon alfa-2a (40KD)) on the response rate of normal ALT and HDV RNA-negativity in patients with chronic hepatitis D

Brief Summary: This study will evaluate the efficacy and safety of 48 weeks` treatment with PEGASYS monotherapy in patients with chronic hepatitis D. Treatment is followed by 24 weeks 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 40.

Study Phase: III

Study Design / Study Details:

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

Study Type:

Condition: Hepatitis D, Chronic

Intervention Type: Drug

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

Primary Outcome: 1. Reponse rate of normal ALT and HDV RNA-negativity (HDV-RNA levels) at end of follow-up (week 72).

Key Secondary Outcomes: 1. Efficacy: Response rate of normal ALT and HDV RNA-negativity at week 48; suppression of HBV DNA below 1x105 at weeks 48 and 72; HBsAg levels, loss of HBsAg and presence of HBsAb at weeks 48 and 72. Safety: 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, 2005

Trial Registration Date: 03/10/2006

Date Last Updated: 10/17/2008

Link To Trial Results

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Trial listings updated: November 17, 2008 at 2:40:10 PM