NCT02219477

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

An Open-Label 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 (TURQUOISE-CPB)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	ombitasvir/paritaprevir/ritonavir	tablet; paritaprevir co-formulated with ritonavir and ombitasvir
DRUG	dasabuvir	tablet
DRUG	ribavirin	tablet

Timeline

• Start date: 2014-11-24
• Primary completion: 2016-06-13
• Completion: 2017-03-03
• First posted: 2014-08-19
• Last updated: 2017-07-11
• Results posted: 2017-07-11