CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 615 enrolled
Drug / intervention
ABT-450/r/ABT-267 +2 moredrug
Likely dose
Ribavirin (RBV) 200 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/NCT02167945
NCT02167945Phase 3Completed
CompareCT.gov

An Open-Label, Multicenter Study to Evaluate Long-term Outcomes With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-II)

AbbVie·interventional·Posted Jun 19, 2014·Updated Jul 19, 2022

In Brief

A Phase 3 clinical trial evaluating ABT-450/r/ABT-267, ABT-333, and 1 other intervention for Chronic Hepatitis C Virus (HCV) Infection Genotype 1. Completed, enrolled 615 participants across 48 sites.

Detailed Summary

The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Virus (HCV) Infection Genotype 1
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 19, 2014
Enrollment StartJun 12, 2014
Primary CompletionMay 13, 2021
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 12.0 years ago

Interventions

ABT-450/r/ABT-267drug

Tablet for oral use

ABT-333drug

Tablet for oral use

Ribavirin (RBV)drug

Ribavirin was provided as 200 mg tablets, and dosed based on weight, 1000 to 1200 mg divided twice daily per local label. For example, for participants weighing \< 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.