drugset / Trial / NCT02259855
Pharmacokinetics (PK) of Tipranavir/Ritonavir, Ribavirin, Pegylated Interferon (Peg INF) in Hepatitis C (HCV) Subjects With Mild Hepatic Impairment and in HCV, Hepatitis B (HBV), Hepatitis D Infected Subjects or Alcoholic Cirrhosis With Moderate Hepatic Impairment
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objectives were: * To determine the effects of steady state TPV co-administered with low dose RTV on steady state PegIFN and RBV in HIV negative subjects with mild hepatic impairment (scheme A) * To determine the effects of steady state of pegylated interferon (PegIFN) and RBV on steady state pharmacokinetics of TPV co-administered with low dose RTV in HIV negative subjects with mild hepatic impairment (scheme A) * To determine the pharmacokinetics of single dose and steady state TPV/r 500/200 mg in subjects with moderate hepatic insufficiency (scheme B)
Timeline
- Start
- 2006-01-01
- Primary completion
- 2008-10-01
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | — | — |
| Subject | Ribavirin | Small molecule | — | — |
| Subject | Ritonavir | Other / unclassified | 200 mg | — |
| Subject | Tipranavir | Small molecule | 500 mg | — |