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: September 22, 2014
Last verified: September 2014
  Purpose

This 4 arm study is designed for patients with CHC who have not responded to peg interferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initia l 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: Ribavirin
Drug: peginterferon alfa-2a [Pegasys]
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: Ribavirin
1000/1200mg po daily for 72 weeks
Drug: peginterferon alfa-2a [Pegasys]
360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks
Experimental: 2 Drug: Ribavirin
1000/1200mg po daily for 48 weeks
Drug: peginterferon alfa-2a [Pegasys]
360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks.
Experimental: 3 Drug: Ribavirin
1000/1200mg po daily for 72 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 72 weeks
Active Comparator: 4 Drug: Ribavirin
1000/1200mg po daily for 48 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 22, 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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014