CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
ombitasvir, paritaprevir/r, dasabuvir + ribavirin +1 moredrug
Likely dose
ombitasvir, paritaprevir/r, dasabuvir + ribavirin 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/NCT02461745
NCT02461745Phase 4Completed
CompareCT.gov

A Phase IV, Multisite Study of the Treatment of Chronic Hepatitis C Virus Infection Genotype 1 in a Real World Large Health Maintenance Organization: An Evaluation of Real World Sustained Virological Response and Patient Reported Outcomes

Kaiser Permanente·interventional·Posted Jun 3, 2015·Updated Jan 22, 2021

In Brief

A Phase 4 clinical trial evaluating ombitasvir, paritaprevir/r, dasabuvir + ribavirin and ombitasvir, paritaprevir/r, dasabuvir for Hepatitis C, Chronic. Completed, enrolled 200 participants across 4 sites.

Detailed Summary

This is a Phase IV, open-label, multi-center study to evaluate the real world sustained virological response rate, subject adherence, and subject reported outcomes during and after treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older, with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesUnited States
CollaboratorsAbbVie

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 3, 2015
Enrollment StartJun 1, 2015
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.1 years ago

Interventions

ombitasvir, paritaprevir/r, dasabuvir + ribavirindrug

VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets) + RBV (ribavirin tablets) for 12 weeks

ombitasvir, paritaprevir/r, dasabuvirdrug

VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets)