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Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)
This study is currently recruiting participants.
Verified by Schering-Plough, January 2009
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00423800
  Purpose

This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 vs 48 weeks therapy with peginterferon alfa-2b + ribavirin at standard doses in naïve HCV genotype 1 high viral load (HVL) patients who are HCV-RNA negative at Week 4. HVL will be defined as HCV-RNA of >600,000 IU/mL prior to the initiation of therapy. Patients with genotype 1 baseline HVL prescribed PEGETRON (peginterferon and ribavirin) in the usual manner in accordance with the marketing authorization and are viral negative at Week 4 will be randomized at Week 8 to receive a total of 24 or 48 weeks of therapy. Subjects will be required to have their baseline and week-12 viral load analyzed by the same local laboratory using the standard of care test used by the site. Qualitative testing at Week 4, 8, 16-20, 24, and 48 may be conducted either by local laboratory or a central laboratory identified by the sponsor using an assay specified by the sponsor. No additional interventions outside of the clinic's standard of care and the conditions of the Canadian product monograph for PEGETRON will be applied to subjects.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Combination of pegylated interferon alfa-2b and ribavirin
Phase III

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Ribavirin Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferons BaseLine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) Therapy (1.5 Mcg/kg/Week + 800-1200 mg/Day) in Naïve Genotype 1 Hepatitis C Patients With High Baseline Viral Load Who Are HCV-RNA Negative at Week 4 and Week 12

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Sustained virologic response, defined as HCV-RNA negative (below limit of detection) 24 weeks following the completion of therapy [ Time Frame: 24 weeks following completion of up to 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse rate, defined as the percentage of subjects with negative virology at end of treatment, but positive virology at 24 weeks of follow up post treatment. [ Time Frame: 24 weeks following completion of up to 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 212
Study Start Date: December 2006
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm A: Experimental
Subjects are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
Drug: Combination of pegylated interferon alfa-2b and ribavirin
  1. Powder for Solution in Redipen® (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 or 48 weeks
  2. 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 or 48 weeks
Arm B: Active Comparator
Subjects are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
Drug: Combination of pegylated interferon alfa-2b and ribavirin
  1. Powder for Solution in Redipen® (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 or 48 weeks
  2. 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 or 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with chronic HCV.
  • Between 18 and 65 years of age.
  • a. HCV positive, >600,000 IU/mL at baseline AND b. Genotype 1.
  • Suitable for treatment with PEGETRON per the Canadian product monograph.
  • Investigator has already decided to treat with PEGETRON REDIPEN®.
  • HCV-RNA negative at treatment week 4.
  • Meet certain minimum laboratory values at the week 8 screening visit.

Exclusion Criteria:

  • Had previous interferon-based therapy for Chronic Hepatitis C.
  • Active HBV infection.
  • HIV antibody positive.
  • Cirrhotic.
  • Severe depression or psychoses.
  • Uncontrolled epilepsy.
  • Use of illicit drugs.
  • History of non-compliance to medical regimens.
  • Liver disease other than from chronic hepatitis C.
  • Participating in any other clinical study.
  • Used any investigational drugs within 30 days of screening.
  • < 40 kg or > 125 kg.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423800

Contacts
Contact: SP Clinical Trial Registry Call Center 1-888-772-8734

Locations
Canada
Investigational Site 13 Recruiting
Kingston, Canada, K7L 5G2
Investigational Site 14 Recruiting
Toronto, Canada, M4N 3M5
Investigational Site 7 Recruiting
Winnipeg, Canada, R3E 3P4
Investigational Site 21 Completed
Vancouver, Canada, V5Z 1H2
Investigational Site 9 Recruiting
London, Canada, N6A 5R9
Investigational Site 15 Recruiting
Toronto, Canada, M6H 3M1
Investigational Site 27 Recruiting
Vancouver, Canada, V6A 4B6
Investigational Site 19 Completed
Montreal, Canada, H3A 1A1
Investigational Site 6 Recruiting
Edmonton, Canada, T5H 4B9
Investigational Site 23 Recruiting
Halifax, Canada, B3H 1V7
Investigational Site 24 Recruiting
Edmonton, Canada, T6G 2B7
Investigational Site 18 Recruiting
Montreal, Canada, H3T 1E2
Sponsors and Collaborators
Schering-Plough
  More Information

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P05016
Study First Received: January 17, 2007
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00423800  
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009