Overview

This trial is active, not recruiting.

Conditions chronic hepatitis c, decompensated cirrhosis, hepatitis c virus
Treatments abt-450/ritonavir/abt-267, abt-333, ribavirin
Phase phase 3
Sponsor AbbVie
Start date November 2014
End date June 2016
Trial size 60 participants
Trial identifier NCT02219477, 2014-001477-13, M14-227

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ABT-450/r/ABT-267 plus ABT-333 with ribavirin (RBV) for 12 weeks
abt-450/ritonavir/abt-267 ombitasvir/ABT-450/ritonavir
tablet
abt-333 dasabuvir
tablet
ribavirin RBV
tablet
(Experimental)
ABT-450/r/ABT-267 plus ABT-333 with ribavirin (RBV) for 24 weeks
abt-450/ritonavir/abt-267 ombitasvir/ABT-450/ritonavir
tablet
abt-333 dasabuvir
tablet
ribavirin RBV
tablet
(Experimental)
ABT-450/r/ABT-267 with ribavirin (RBV) for 24 weeks
abt-450/ritonavir/abt-267 ombitasvir/ABT-450/ritonavir
tablet
abt-333 dasabuvir
tablet
ribavirin RBV
tablet

Primary Outcomes

Measure
Percentage of participants with Sustained Virologic Response 12 weeks post-treatment
time frame: 12 weeks after the last actual dose of study drug

Secondary Outcomes

Measure
Percentage of participants with virologic failure during treatment
time frame: Up to 24 weeks while on treatment followed by 48 weeks after last actual dose of study drug
Percentage of participants with virologic relapse post-treatment
time frame: Up to 48 weeks after the last actual dose of study drug
Percentage of participants with improvement in laboratory parameters associated with hepatic function
time frame: Up to Post-treatment Week 12
Percentage of Genotype 4 participants with Sustained Virologic Response 12 weeks post-treatment
time frame: 12 weeks after the last actual dose of study drug

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: 1. HCV Genotype 1(GT1)- or Genotype 4 (GT4)-infection defined as: Positive for anti-HCV Ab, HCV RNA > 1,000 IU/mL and laboratory result indicating HCV GT1 infection at Screening. 2. Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e., CT or MRI). 3. Child-Pugh Score 7 - 9 inclusive at time of Screening. Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab). 3. Prior or current use of any other investigational or commercially available anti-HCV agents other than interferon/RBV and/or pegylated interferon (pegIFN)/RBV (including but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir). 4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI). 5. Any current or past evidence of Child-Pugh C classification.

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.