CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 68 enrolled
Drug / intervention
ombitasvir/paritaprevir/ritonavir +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/NCT02207088
NCT02207088Phase 3Completed
CompareCT.gov

An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-I)

AbbVie·interventional·Posted Aug 1, 2014·Updated Nov 9, 2017

In Brief

A Phase 3 clinical trial evaluating ombitasvir/paritaprevir/ritonavir, dasabuvir, and 1 other intervention for Chronic Hepatitis C and 4 related conditions. Completed, enrolled 68 participants.

Detailed Summary

This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) \<30, including those on hemodialysis or peritoneal dialysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis, Severe Renal Impairment, End-stage Renal Disease
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 1, 2014
Enrollment StartSep 23, 2014
Primary CompletionDec 6, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.9 years ago

Interventions

ombitasvir/paritaprevir/ritonavirdrug

tablet

dasabuvirdrug

tablet

Ribavirindrug

tablet