Trial Information

Summary: A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Combination with Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated with PEG-Intron + Ribavirin

Status: Completed

Protocol Number: ML16965

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the safety and tolerability of PEGASYS plus ribavirin in patients with chronic hepatitis C viral infection who could not tolerate or were unresponsive to PEG-Intron plus ribavirin

Brief Summary: This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is >100 individuals. Target sample size is 57.

Study Phase: IV

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Hepatitis C, Chronic

Intervention Type: Drug

Intervention Name: peginterferon alfa-2a [PEGASYS]

Primary Outcome: 1. Proportion of patients able to complete prescribed length of Pegasys plus ribavirin therapy Time frame: 36 and 60 weeks

Key Secondary Outcomes: 1. Sum score of Beck Depression Inventory and Fatigue Severity Score, proportion of patients with each flu-like symptom, >=2 log drop or undetectable HCV-RNA, or normal ALT levels, adverse events, laboratory values Time frame: Throughout study

Inclusion Criteria:

  • adult patients at least 18 years of age
  • CHC infection, genotype 1
  • unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks of treatment
  • use of 2 forms of contraception during the study in both men and women

Exclusion Criteria:

  • women who are pregnant or breast-feeding
  • medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
  • patients with decompensated cirrhosis
  • patients receiving any systemic antiviral therapy or investigational drug, other than PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 08/26/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Pasadena, CA 91107
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: September 2, 2008 at 2:13:19 PM


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