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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02219477
• Date of registration: 15/08/2014
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: 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 TURQUOISE-CPB
• Scientific 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)
• Date of first enrolment: November 24, 2014
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02219477
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada, Germany, United States

Contacts

• Name: Eric Cohen, MD
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

1. HCV GT1- or GT4-infection defined as: positive for anti-HCV Ab, HCV RNA > 1,000 IU/mL
and laboratory result indicating HCV GT1 or GT4 infection at Screening.

2. Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e.,
computed tomography [CT] scan or magnetic resonance imaging [MRI]).

3. Child-Pugh Score of 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
CT scan or 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.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Decompensated Cirrhosis

Hepatitis C Virus

Chronic Hepatitis C

Intervention(s)

Drug: dasabuvir

Drug: ombitasvir/paritaprevir/ritonavir

Drug: ribavirin

Primary Outcome(s)

Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2 [Time Frame: 12 weeks after the last actual dose of study drug]

Secondary Outcome(s)

Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest [Time Frame: Up to post-treatment Week 12]

Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure [Time Frame: Up to 24 weeks during treatment]

Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse?12 [Time Frame: Up to 12 weeks after the last actual dose of study drug]

Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests [Time Frame: Up to post-treatment Week 12]

Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score [Time Frame: Up to post-treatment Week 12]

Percentage of Participants With SVR12 in Group 3 [Time Frame: 12 weeks after the last actual dose of study drug]

Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score [Time Frame: Up to post-treatment Week 12]

Secondary ID(s)

M14-227

2014-001477-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/07/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02219477