CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
ABT-267 +3 moredrug
Likely dose
ABT-267 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01314261
NCT01314261Phase 2Completed
CompareCT.gov

A Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of ABT-267 in Combination With Peginterferon Alpha-2a and Ribavirin (pegIFN/RBV) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

AbbVie (prior sponsor, Abbott)·interventional·Posted Mar 14, 2011·Updated Jul 2, 2018

In Brief

A Phase 2 clinical trial evaluating ABT-267, Pegylated interferon (pegIFN), and 2 other interventions for Chronic Hepatitis C and Hepatitis C Virus (HCV) Infection. Completed, enrolled 37 participants across 11 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C, Hepatitis C Virus (HCV) Infection
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2011
Enrollment StartMar 1, 2011
Primary CompletionJan 1, 2012
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.3 years ago

Interventions

ABT-267drug

5 mg or 25 mg tablets

Pegylated interferon (pegIFN)drug

Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly

Ribavirin (RBV)drug

200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day

Placebo for ABT-267other

Participants received matching placebo tablet at each dose level for ABT-267.