drugset / Trial / NCT01314261

Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

NCT01314261

Phase 2 Completed 37 enrolled AbbVie
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected participants.

Timeline

Start
2011-03
Primary completion
2012-01
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject ombitasvir Small molecule 5 mg
Subject ombitasvir Small molecule 50 mg
Subject ombitasvir Small molecule 200 mg
Background Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Background Ribavirin Small molecule 1000 mg
Background Ribavirin Small molecule 1200 mg