Clinical trial NCT02216422: A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection
Official title: An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (Turquoise-IV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Virus (HCV) Infection
Keywords: Chronic Hepatitis C
Hepatitis C
Hepatitis C Virus
Hepatitis C Genotype 1b
Interferon-Free
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults.

Detailed description: The primary objective of this study was to assess the safety and efficacy (the percentage of participants achieving a 12-week sustained virologic response (SVR12), \[HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks following treatment\]) of co-formulated ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/r) and dasabuvir co-administered with RBV for 12 weeks in HCV genotype 1b-infected adult participants with compensated cirrhosis. The secondary objectives of this study were to assess the number and percentage of participants with virologic failure during treatment and the percentage of participants with relapse post-treatment.

Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening)
* Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening
* Participant had never received antiviral treatment (including pegIFN/RBV) for hepatitis C infection (treatment-naïve participant) or had documentation of meeting one of the defined categories of a treatment-experienced participants
* Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3 months prior to screening or a negative ultrasound at screening.
* Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
* Males must have been surgically sterile, or agreed to practice 2 effective methods of birth control throughout the course of the study.

Exclusion Criteria:

* Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
* Evidence of current or past Child-Pugh B or C classification
* Confirmed presence of hepatocellular carcinoma
* Abnormal laboratory tests
* Participant who self-reported on average drinking more than 2 drinks per day for current drinkers
* Previous treatment with a direct acting antiviral agent (DAA) containing regimen
* History of solid organ transplant.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
timeFrame: Post-treatment Day 1 to Post-treatment Week 12
Secondary outcomes:
measure: Percentage of Participants With On-Treatment Virologic Failure
timeFrame: Day 1 through Week 12
measure: Percentage of Participants With Post-Treatment Relapse
timeFrame: Post-treatment Day 1 to Post-treatment Week 12
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Rolando M Viani, MD
role: STUDY_DIRECTOR
References: