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A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00800748
First received: December 1, 2008
Last updated: January 26, 2017
Last verified: January 2017

December 1, 2008
January 26, 2017
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Occurrence rate and intensity of adverse events [ Time Frame: Throughout study ]
Complete list of historical versions of study NCT00800748 on ClinicalTrials.gov Archive Site
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  • Sustained viral response [ Time Frame: End of treatment (weeks 24 or 48) ]
  • Viral response rate [ Time Frame: At week 12, and at end of treatment (weeks 24 or 48) ]
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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.
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Expanded Access
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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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)
Sexes Eligible for Study: All
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 ( EudraCT Number )
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Hoffmann-La Roche
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2017

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