A Study of Combination Treatment With PEGASYS (Peginterferon Alfa-2a (40KD) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00800748
First received: December 1, 2008
Last updated: April 7, 2014
Last verified: April 2014

December 1, 2008
April 7, 2014
January 2006
August 2010   (final data collection date for primary outcome measure)
Occurrence rate and intensity of adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Occurence rate and intensity of adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00800748 on ClinicalTrials.gov Archive Site
  • Sustained viral response [ Time Frame: End of treatment (weeks 24 or 48) ] [ Designated as safety issue: No ]
  • Viral response rate [ Time Frame: At week 12, and at end of treatment (weeks 24 or 48) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Combination Treatment With PEGASYS (Peginterferon Alfa-2a (40KD) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C.
An Open Label Study Assessing the Safety and Effect on Viral Response of Combination Therapy With PEGASYS + COPEGUS in Selected Groups of Patients With Chronic Viral Hepatitis C

This 3 arm study will assess the safety and efficacy of combination treatment with PEGASYS + Copegus in patients with chronic hepatitis C. Three groups of patients will be studied; 1) those with elevated ALT level, 2) those with normal ALT level, and 3) those with HIV co-infection. Patients with genotype 1, 4, 5 or 6 will receive PEGASYS 180 micrograms sc once weekly + Copegus 1000-1200mg po daily (dependent on body weight) for 48 weeks, those with genotype 2 or 3 will receive PEGASYS 180 micrograms sc once weekly + Copegus 800mg po daily for 24 weeks, and all patients with HIV co-infection will receive PEGASYS 180 micrograms sc once weekly + Copegus 800mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: peginterferon alfa-2a [Pegasys]
    180 micrograms sc weekly for 48 weeks (genotype 1, 4, 5, 6), or 24 weeks (genotype 2, 3)
  • Drug: peginterferon alfa-2a [Pegasys]
    180 micrograms sc weekly for 48 weeks
  • Drug: ribavirin [Copegus]
    1000-1200mg po daily for 48 weeks (genotype 1, 4, 5, 6) or 800mg po daily for 24 weeks (genotype 2,3)
  • Drug: ribavirin [Copegus]
    800mg po daily for 48 weeks
  • Experimental: 1
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: ribavirin [Copegus]
  • Experimental: 2
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: ribavirin [Copegus]
  • Experimental: 3
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: ribavirin [Copegus]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
373
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients >= 18 years of age;
  • chronic hepatitis C, with detectable serum HCV RNA;
  • scheduled for treatment with PEGASYS;
  • compensated liver disease.

Exclusion Criteria:

  • chronic liver disease other than chronic hepatitis C;
  • active HAV or HBV infection;
  • therapy with any systemic antiviral, antineoplastic or immunomodulatory treatment <= 6 months prior to first dose of study drug.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Slovakia
 
NCT00800748
ML19387
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP