Trial Information

Summary: REPEAT study - A Study of PEGASYS (Peginterferon alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon alfa-2b (12KD))/Ribavirin Combination Therapy

Status: Completed

Protocol Number: MV17150

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of PEGASYS combined with ribavirin on sustained virologic response in patients with chronic hepatitis C who did not respond to previous Pegintron/ribavirin combination therapy

Brief Summary: This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. Target sample size is 888.

Study Phase: IV

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Hepatitis C, Chronic

Intervention Type: Drug

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

Primary Outcome: 1. Sustained virological response rate Time frame: 24 weeks post-treatment

Key Secondary Outcomes: 1. Percentage of patients with >=2log drop in HCV-RNA Time frame: Weeks 12 and 24 2. Percentage of patients with undetectable HCV-RNA Time frame: Weeks 12, 24 and end of treatment

Inclusion Criteria:

  • adult patients >=18 years of age;
  • CHC infection;
  • liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
  • use of 2 forms of contraception during study and 6 months after the study in both men and women;
  • Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks.

Exclusion Criteria:

  • women who are pregnant or breastfeeding;
  • male partners of women who are pregnant;
  • conditions associated with decompensated liver disease;
  • other forms of liver disease, including liver cancer;
  • human immunodeficiency virus infection.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 07/26/2005

Date Last Updated: 09/19/2008

Link To Trial Results

Contact:

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

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: October 6, 2008 at 2:57:06 PM


Back to Centerwatch Trial Listing by Location


Additional resources
in this illness area

Copyright © 1995 - 2008, CenterWatch
All Rights Reserved

This site was developed in association with Illumina Interactive, Boston, MA