Clinical trial 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
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Decompensated Cirrhosis
Hepatitis C Virus
Keywords: Cirrhosis
Hepatitis C
Child-Pugh B
Hepatitis C Genotype 4
Interferon-Free
Hepatitis C Genotype 1
Chronic Hepatitis C
Decompensated Cirrhosis
Hepatitis C Virus
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-08-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2
timeFrame: 12 weeks after the last actual dose of study drug
Secondary outcomes:
measure: Percentage of Participants With SVR12 in Group 3
timeFrame: 12 weeks after the last actual dose of study drug
measure: Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure
timeFrame: Up to 24 weeks during treatment
measure: Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12
timeFrame: Up to 12 weeks after the last actual dose of study drug
measure: Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests
timeFrame: Up to post-treatment Week 12
measure: Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest
timeFrame: Up to post-treatment Week 12
measure: Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score
timeFrame: Up to post-treatment Week 12
measure: Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score
timeFrame: Up to post-treatment Week 12
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Eric Cohen, MD
role: STUDY_DIRECTOR
References: