Clinical trial NCT01674725: A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C
Official title: A Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Antiviral Activity of the Combination of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 With and Without Ribavirin in Treatment-Experienced Subjects With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C virus
Hepatitis C Genotype 1
Hepatitis C
Interferon-Free
Chronic Hepatitis C
Ombitasvir
Ribavirin
Viekira PAK
Dasabuvir
Paritaprevir
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-08-29
Enrollment: 187
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 antiviral activity 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) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.

Detailed description: A randomized, open-label, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-experienced, noncirrhotic participants with chronic hepatitis C virus genotype 1b (HCV GT1b) infection.

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
* Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
* Subject's hepatitis C virus genotype is subgenotype 1b at Screening without co infection with any other genotype/subgenotype.

Exclusion Criteria:

* Significant liver disease with any cause other than HCV as the primary cause
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
* Positive screen for drugs or alcohol
* Use of contraindicated medications within 2 weeks of dosing

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses
timeFrame: 12 weeks after last dose of study drug
Secondary outcomes:
measure: Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment
timeFrame: Baseline (Day 1) and Week 12 (End of Treatment)
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses
timeFrame: 12 weeks after last dose of study drug
measure: Percentage of Participants With Virologic Failure During Treatment
timeFrame: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12
measure: Percentage of Participants With Virologic Relapse After Treatment
timeFrame: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Jeffrey Enejosa, MD
role: STUDY_DIRECTOR
References:
citation: Andreone P, Colombo MG, Enejosa JV, Koksal I, Ferenci P, Maieron A, Mullhaupt B, Horsmans Y, Weiland O, Reesink HW, Rodrigues L Jr, Hu YB, Podsadecki T, Bernstein B. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology. 2014 Aug;147(2):359-365.e1. doi: 10.1053/j.gastro.2014.04.045. Epub 2014 May 9.
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.