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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00922779
First received: June 16, 2009
Last updated: August 4, 2014
Last verified: August 2014

June 16, 2009
August 4, 2014
June 2002
June 2012   (final data collection date for primary outcome measure)
Adverse events; laboratory parameters [ Time Frame: Throughout study; recorded at each clinic visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00922779 on ClinicalTrials.gov Archive Site
Sustained viral response [ Time Frame: 24 weeks after end of therapy ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C
Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C

This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will rec eive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and bod y weight (< and >75kg)in combination with PEGASYS 180micrograms sc weekly. The a nticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: peginterferon alfa-2a [Pegasys]
    180micrograms sc weekly for 12-48 weeks
  • Drug: ribavirin
    800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)
Experimental: 1
Interventions:
  • Drug: peginterferon alfa-2a [Pegasys]
  • 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
7754
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • serological evidence of chronic hepatitis C;
  • detectable serum HCV-RNA;
  • liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion Criteria:

  • history or other evidence of a medical condition associated with chronic liver disease other than HCV;
  • co-infection with active hepatitis A or B;
  • hepatocellular carcinoma;
  • patients with severe cardiovascular disease whose condition may worsen due to acute anemia.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00922779
ML16709
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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