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: December 10, 2015
Last verified: December 2015
  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: 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:
  • Number of Participants With Sustained Virological Response Rate [ Time Frame: Up to 72 weeks (Group A) and 48 weeks (Group D) ] [ Designated as safety issue: No ]
    Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.


Secondary Outcome Measures:
  • Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D) [ Time Frame: At Week 48 and Week 72 ] [ Designated as safety issue: No ]
    SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.

  • Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D) [ Time Frame: At Week 48 and Week 72 ] [ Designated as safety issue: No ]
    SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.

  • Percentage of Participants With Undetectable HCV-RNA [ Time Frame: At Week 12, 24, 48 and EOT ] [ Designated as safety issue: No ]

    The percentage of participants with a undetectable HCV RNA 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 IU/mL measured >= 20 weeks after treatment end, ie, >=140 days after treatment end) are reported.

    End-of-treatment (EOT) virological response is defined as last HCV RNA measurement that is not detectable (<50 IU/mL) at study day of last dose of study medication (+/- 28 days).


  • Percentage of Participants With >=2log Drop in HCV-RNA [ Time Frame: At Week 12 and 24 ] [ Designated as safety issue: No ]
    Reduction in HCV-RNA titers of at least 2 log10 after 12/24 weeks of study treatment (i.e. 99% reduction of viral load) was analyzed. Percentage of participants with at least a 2 log10 drop of HCV-RNA at study week 12 and 24 (lower limit of quantitation 600 IU/mL) as compared to baseline or non-detectable HCV-RNA (lower limit of detection 50 IU/mL) were reported.

  • Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D) [ Time Frame: At Week 12 and 24 ] [ Designated as safety issue: No ]
    The mean change from baseline in HCV RNA level (reduction in viral load) at Week 12 and 24 were determined. HCV RNA result were not detectable (<50 IU/ML) and not quantifiable (<600 IU/ML). Baseline value were assessed on Day 1 before the administration of the first dose of study drug.

  • Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response [ Time Frame: Week 96 (Group A and C) and Week 72 (Group B and D) ] [ Designated as safety issue: No ]
    Maintenance of end-of-treatment virological response was assessed based on all participants treated and according to the actual treatment period (backward imputation method). The percentage of participants who maintained their end-of-treatment virological response was determined. Maintenance of actual end-of-treatment virological response was calculated by dividing the number of participants with a virological response both at the end of the actual untreated follow-up period and at the end of the actual treatment period by the number of participants with a virological response at the actual end of treatment.

  • Percentage of Participants With Relapse After End of Treatment [ Time Frame: Week 96 (Group A and C) and Week 72 (Group B and D) ] [ Designated as safety issue: No ]
    The percentage of participants who relapsed (loss of response) after having achieved a virological response at the end of treatment was determined.


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   (Adult, Senior)
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 104 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
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
Results First Received: December 10, 2015
Last Updated: December 10, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 24, 2016