Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants 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: February 1, 2016
Last verified: February 2016

December 1, 2008
February 1, 2016
January 2006
August 2010   (final data collection date for primary outcome measure)
Incidence of adverse events [ Time Frame: up to approximately 3 years ] [ Designated as safety issue: No ]
Occurrence 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
  • Percentage of participants with sustained viral response [ Time Frame: 24 weeks after the end of treatment (Week 48) ] [ Designated as safety issue: No ]
  • Percentage of participants with viral response rate [ Time Frame: Week 12 after the end of treatment (Week 48) ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C
An Open, Phase IV, Multicentric Study, Evaluating Safety and Efficacy of Ribavirin (Copegus®) and Peginterferon Alfa-2a (Pegasys®) Combination in Specific Groups
This 3 arm study will assess the safety and efficacy of combination treatment with peginterferon alfa-2a + ribavirin in participants with chronic hepatitis C. Three groups of participants will be studied; 1) those with elevated alanine transaminase (ALT) level, 2) those with normal ALT level, and 3) those with human immunodeficiency virus (HIV) co-infection. Participants with genotype 1, 4, 5 or 6 will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) once weekly (qw) + ribavirin 1000-1200 milligrams (mg) orally (PO) daily (dependent on body weight) for 48 weeks, those with genotype 2 or 3 will receive peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks, and all participants with HIV co-infection will receive peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks. The anticipated time on study treatment is 48 weeks, and the target sample size is 300 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
    Peginterferon alfa-2a will be administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 2, 3, 4, 5, 6 and to particpants with HIV co-infection, or for 24 weeks to participants with genotype 2, and 3.
    Other Name: Pegasys
  • Drug: Ribavirin
    Ribavirin will be administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800mg po daily for 24 weeks to participants with genotype 2, and 3.
    Other Name: Copegus
  • Experimental: Group A
    Participants with genotype 1, 4, 5 or 6 will receive peginterferon alfa-2a 180 mcg SC qw + ribavirin 1000-1200 mg PO daily (dependent on body weight) for 48 weeks.
    Interventions:
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Experimental: Group B
    Participants with with genotype 2 or 3 will receive peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks.
    Interventions:
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Experimental: Group C
    Participants with HIV co-infection will receive peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.
    Interventions:
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
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 participants, greater than or equal to (>=) 18 years of age
  • Chronic hepatitis C, with detectable serum hepatitie C virus (HCV) ribonucleic acid (RNA)
  • Scheduled for treatment with peginterferon alfa-2a
  • Compensated liver disease
  • Women in fertile age must be informed about obligation of using adequate contraception during and 6 month post treatment with ribavirin (Copegus®)
  • Men with a sexual partner in fertile age must be informed about obligatory contraception preventing pregnancy during the course of treatment with ribavirin (Copegus®)as well as 6 months after treatment cessation
  • Female participants in the study must have a negative pregnancy test performed not sooner than within 2 weeks preceding the planned inclusion to the study
  • Men with a sexual partner in fertile age must produce a negative result of the partner's pregnancy test performed not sooner than within 2 weeks preceding the planned partner's inclusion to the study

Exclusion Criteria:

  • Chronic liver disease other than chronic hepatitis C
  • Active hepatitis A virus or hepatitis B virus infection
  • Therapy with any systemic antiviral, antineoplastic or immunomodulatory treatment less than or equal to (<=) 6 months prior to first dose of study drug
  • Hemoglobin <120 grams per liter (g/L) in female subjects or <130 g/L in male subjects (the result must not be older than 2 weeks prior to inclusion to the study)
  • The platelet count <90 x 10^9/liter (the result must not be older than 2 weeks prior to inclusion to the study
  • Neutrofils count <1.5 x 10^9/liter (the result must not be older than 2 weeks prior to inclusion to the study)
  • Subjects with increased risk of anaemia, or subjects, at risk of serious health problems resulting from anaemia or decrease of hemoglobin (e.g., subjects with serious cardiovascular or cerebrovascular disease)
  • History or presence of a serious mental disease, especially depression, which, according to investigator's opinion, does not allow administration of peginterferon alfa-2a (Pegasys®)
  • History or presence of a disease consequent to immunodeficiency (e.g., inflammatory diseases of intestine, idiopathic thrombocytopenic purpura, systemic lupus erythematodes, rheumatoid arthritis)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Slovakia
 
NCT00800748
ML19387, 2005-003932-23
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2016

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