CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 10 enrolled
Drug / intervention
ombitasvir/paritaprevir/ritonavir, dasabuvir +2 moredrug
Likely dose
Not stated in 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/NCT02399345
NCT02399345Phase 3Completed
CompareCT.gov

An Open-Label, Treatment Duration-Ranging Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/ Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Naive Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

AbbVie·interventional·Posted Mar 26, 2015·Updated Dec 12, 2016

In Brief

A Phase 3 clinical trial evaluating ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir (SOF), and 1 other intervention for Chronic Hepatitis C Virus (HCV Infection Genotype 1). Completed, enrolled 10 participants.

Detailed Summary

This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 26, 2015
Enrollment StartMar 1, 2015
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.3 years ago

Interventions

ombitasvir/paritaprevir/ritonavir, dasabuvirdrug

tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

sofosbuvir (SOF)drug

tablet

ribavirin (RBV)drug

tablet