drugset / Trial / NCT02864199
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
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2004-02
- Primary completion
- 2007-09
- Completion
- 2007-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 135 ug | Subcutaneous |
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Subject | Ribavirin | Small molecule | 200 mg | — |
| Subject | Ribavirin | Small molecule | 400 mg | — |
| Subject | Ribavirin | Small molecule | 600 mg | — |
| Subject | Ribavirin | Small molecule | 800 mg | — |
| Subject | Ribavirin | Small molecule | 1200 mg | — |