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A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis

NCT02219477 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-07-11

Study results available
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Summary

The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.

Conditions

  • Chronic Hepatitis C
  • Decompensated Cirrhosis
  • Hepatitis C Virus

Interventions

DRUG

ombitasvir/paritaprevir/ritonavir

tablet; paritaprevir co-formulated with ritonavir and ombitasvir

DRUG

dasabuvir

tablet

DRUG

ribavirin

tablet

Sponsors & Collaborators

Principal Investigators

  • Eric Cohen, MD · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-24
Primary Completion
2016-06-13
Completion
2017-03-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02219477 on ClinicalTrials.gov