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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00087646
First received: July 12, 2004
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Drug: Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virological response rate [ Time Frame: 24 weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with >=2log drop in HCV-RNA [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Percentage of patients with undetectable HCV-RNA [ Time Frame: Weeks 12, 24 and end of treatment ] [ Designated as safety issue: No ]

Enrollment: 948
Study Start Date: September 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a [Pegasys]
360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks
Drug: Ribavirin
1000/1200mg po daily for 72 weeks
Experimental: 2 Drug: peginterferon alfa-2a [Pegasys]
360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks.
Drug: Ribavirin
1000/1200mg po daily for 48 weeks
Experimental: 3 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 72 weeks
Drug: Ribavirin
1000/1200mg po daily for 72 weeks
Active Comparator: 4 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks
Drug: Ribavirin
1000/1200mg po daily for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087646

  Show 108 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00087646     History of Changes
Other Study ID Numbers: MV17150
Study First Received: July 12, 2004
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 21, 2014