Overview

A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment

Status:
Completed

Trial end date:
2007-09-01

Target enrollment:

Participant gender:

Summary

This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target sample size is 48 individuals.

Phase:

Phase 4

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Interferon-alpha
Peginterferon alfa-2a
Ribavirin