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

NCT02259855

Phase 1 Completed 36 enrolled Boehringer Ingelheim
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

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2a Protein / enzyme biologic
Subject Ribavirin Small molecule
Subject Ritonavir Other / unclassified 200 mg
Subject Tipranavir Small molecule 500 mg

Indications