CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 18 enrolled
Drug / intervention
ombitasvir/paritaprevir/ritonavir and dasabuvir +1 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/NCT02487199
NCT02487199Phase 3Completed
CompareCT.gov

An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-II)

AbbVie·interventional·Posted Jul 1, 2015·Updated Dec 4, 2017

In Brief

A Phase 3 clinical trial evaluating ombitasvir/paritaprevir/ritonavir and dasabuvir and ombitasvir/paritaprevir/ritonavir for Hepatitis C Virus (HCV). Completed, enrolled 18 participants.

Detailed Summary

This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus (HCV)
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 1, 2015
Enrollment StartSep 30, 2015
Primary CompletionDec 5, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.0 years ago

Interventions

ombitasvir/paritaprevir/ritonavir and dasabuvirdrug

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

ombitasvir/paritaprevir/ritonavirdrug

Tablet; ombitasvir coformulated with paritaprevir and ritonavir