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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferon-alpha; Peginterferon alfa-2a

Criteria

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.