drugset / Trial / NCT01563536

Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects

NCT01563536

Phase 2 Completed 12 enrolled AbbVie
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir) administered as two-day monotherapy followed by ABT-267 in combination therapy with other direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV) infection without cirrhosis.

Timeline

Start
2012-02
Primary completion
2012-04
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject ombitasvir Small molecule 1.5 mg
Subject ombitasvir Small molecule 25 mg
Background Ribavirin Small molecule 1000 mg
Background Ribavirin Small molecule 1200 mg
Background Ritonavir Other / unclassified 100 mg
Background dasabuvir Small molecule 400 mg
Background paritaprevir Small molecule 150 mg