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

  • 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.
  • Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e., CT or MRI).
  • Child-Pugh Score 7 - 9 inclusive at time of Screening.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab).
  • 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).
  • 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).
  • 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.