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:
Participant gender:
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.