A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure


Tracking Information

Start Date  ICMJEJuly 2007
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: January 18, 2008)
  • Percentage of patients with SVR [ Time Frame: 24 weeks after treatment completion ] [ Designated as safety issue: No ]
  • Percentage of patients with undetectable HCV-RNA [ Time Frame: Week 24 and 48 ] [ Designated as safety issue: No ]
  • Percentage of patients with a 2log10 drop in HCV-RNA [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: May 16, 2007)		Percentage of patients with sustained virological response 24 weeks after treatment completion; percentage with undetectable HCV-RNA at week 24, and week 48; percentage with a 2 log10 drop of HCV-RNA at week 24.
Change HistoryComplete list of historical versions of study NCT00474955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: January 18, 2008)		SAEs, premature withdrawals, AEs and laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: May 16, 2007)		SAEs, premature withdrawals, clinically significant AEs and laboratory abnormalities.

Descriptive Information

rief Title  ICMJEA Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.
Official Title  ICMJEAn Open Label Study of the Effect of PEGASYS on Sustained Virological Response in Patients With Chronic Hepatitis C and Chronic Renal Failure
Brief Summary

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of <15mL/min will receive a reduced dose of 135 micrograms weekly. Following 48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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  ICMJEDrug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks
Study Arms / Comparison Groups1: Experimental
Intervention: Drug: peginterferon alfa-2a (40KD) [PEGASYS]

Recruitment Information

Estimated Enrollment  ICMJE150
Estimated Completion DateDecember 2012
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, 18-60 years of age;
  • chronic hepatitis C;
  • chronic renal failure, including patients on hemodialysis therapy;
  • detectable HCV RNA levels (>500IU/mL).

Exclusion Criteria:

  • concurrent active hepatitis A or B;
  • history or evidence of a medical condition associated with chronic liver disease other than HCV;
  • history or other evidence of decompensated liver disease;
  • therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment <=6 months prior to study;
  • acute renal failure.
GenderBoth
Ages18 Years to 60 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: ML20434888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com

Administrative Information

NCT ID  ICMJENCT00474955
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJEML20434
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche