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


Tracking Information

Start Date  ICMJEJune 2002
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2009)		Adverse events; laboratory parameters [ Time Frame: Throughout study; recorded at each clinic visit ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00922779 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: June 16, 2009)		Sustained viral response [ Time Frame: 24 weeks after end of therapy ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C
Official Title  ICMJESafety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C
Brief Summary

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

Detailed Description 
Study PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJEHepatitis C, Chronic
Intervention  ICMJE
  • 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)
Study Arms / Comparison Groups1: Experimental
Interventions:
  • Drug: peginterferon alfa-2a [PEGASYS]
  • Drug: ribavirin

Recruitment Information

Estimated Enrollment  ICMJE6000
Estimated Completion DateAugust 2011
Primary Completion Date 
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: ML16709888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT00922779
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEML16709
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche