CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 74 enrolled
Drug / intervention
ABT-450 +6 moredrug
Likely dose
ABT-450 50 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/NCT01074008
NCT01074008Phase 2Completed

A Blinded, Randomized, Placebo-controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-450 With Ritonavir (ABT-450/r), ABT-333 or ABT-072 Each Administered Alone and in Combination With Peginterferon α-2a and Ribavirin (PegIFN/RBV) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

AbbVie (prior sponsor, Abbott)·interventional·Posted Feb 24, 2010·Updated Jan 8, 2015

In Brief

A Phase 2 clinical trial evaluating ABT-450, ABT-072, and 5 other interventions for Hepatitis C and 3 related conditions. Completed, enrolled 74 participants across 26 sites in 2 countries.

Detailed Summary

This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072 in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2010
Enrollment StartMar 1, 2010
Primary CompletionJun 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.4 years ago

Interventions

ABT-450drug

50 mg capsules co-administered with ritonavir

ABT-072drug

50 mg tablet

ABT-333drug

400 mg tablet

Ritonavirdrug

100 mg capsules co-administered with ABT-450

Peginterferon alpha-2adrug

Syringe, 180 µg/0.5 mL for subcutaneous injections

Ribavirindrug

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

Placeboother

Matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level