Clinical trial NCT01704755: A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis
Official title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Infection
Compensated Cirrhosis
Keywords: Cirrhosis
Hepatitis C
Child Pugh A
Compensated Cirrhosis
Hepatitis C Genotype 1
Cirrhotic
Chronic Hepatitis C
Hepatitis C Virus
ombitasvir
paritaprevir
dasabuvir
Interferon-Free
Viekira Pak
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-10-11
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.

Detailed description: During the treatment period of the study, participants received treatment with ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon completing the treatment period or premature discontinuation of the treatment period, participants entered a 48-week post-treatment period.

Eligibility criteria: Inclusion Criteria:

* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
* Male or female between 18 and 70 years, inclusive, at time of Screening.
* Chronic HCV-infection prior to study enrollment.
* Screening laboratory result indicating HCV genotype 1-infection.
* Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening
* Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

Exclusion Criteria:

* Significant liver disease with any cause other than HCV as the primary cause
* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening.
* Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir.
* Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
* A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment
timeFrame: 12 weeks after the last actual dose of study drug
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm
timeFrame: 12 weeks after the last actual dose of study drug
measure: Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period
timeFrame: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
measure: Percentage of Participants With Virologic Relapse After Treatment
timeFrame: within 12 weeks after the last dose of study drug
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Roger Trinh, MD
role: STUDY_DIRECTOR
References:
citation: Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, Shiffman ML, Wedemeyer H, Berg T, Yoshida EM, Forns X, Lovell SS, Da Silva-Tillmann B, Collins CA, Campbell AL, Podsadecki T, Bernstein B. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med. 2014 May 22;370(21):1973-82. doi: 10.1056/NEJMoa1402869. Epub 2014 Apr 11.
citation: Feld JJ, Bernstein DE, Younes Z, Vlierberghe HV, Larsen L, Tatsch F, Ferenci P. Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Liver Int. 2018 Sep;38(9):1571-1575. doi: 10.1111/liv.13708. Epub 2018 Mar 14.
citation: Forns X, Poordad F, Pedrosa M, Berenguer M, Wedemeyer H, Ferenci P, Shiffman ML, Fried MW, Lovell S, Trinh R, Lopez-Talavera JC, Everson G. Ombitasvir/paritaprevir/r, dasabuvir and ribavirin for cirrhotic HCV patients with thrombocytopaenia and hypoalbuminaemia. Liver Int. 2015 Nov;35(11):2358-62. doi: 10.1111/liv.12931. Epub 2015 Sep 6.