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A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00940420
First Posted: July 16, 2009
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
July 6, 2009
July 16, 2009
November 2, 2016
October 2002
November 2009   (Final data collection date for primary outcome measure)
safety and tolerability with regard to clinical AEs and laboratory parameters [ Time Frame: assessed every 2 weeks throughout study and after 8 weeks follow-up ]
Same as current
Complete list of historical versions of study NCT00940420 on ClinicalTrials.gov Archive Site
safety with regard to hematological parameters [ Time Frame: assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up ]
Same as current
Not Provided
Not Provided
 
A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C
Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C
This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: Copegus (ribavirin)
    800 - 1200 mg po daily for 24 weeks
  • Drug: Copegus (ribavirin)
    800 - 1200 mg po daily for 48 weeks
  • Drug: peginterferon alfa-2a [Pegasys]
    180 mcg sc once weekly for 24 weeks
  • Drug: peginterferon alfa-2a [Pegasys]
    180 mcg sc once weekly for 48 weeks
  • Experimental: A
    Interventions:
    • Drug: Copegus (ribavirin)
    • Drug: peginterferon alfa-2a [Pegasys]
  • Experimental: B
    Interventions:
    • Drug: Copegus (ribavirin)
    • Drug: peginterferon alfa-2a [Pegasys]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2695
November 2009
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients >/= 18 years of age
  • serologic evidence of chronic hepatitis C infection
  • compensated liver disease
  • negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment

Exclusion Criteria:

  • history or other evidence of a medical condition associated with chronic liver disease other than HCV
  • hepatitis A, hepatitis B or HIV infection
  • hepatocellular carcinoma
  • severe concomitant disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00940420
ML16837
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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