A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection
PEARL-I
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I)
2 other identifiers
interventional
316
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
September 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
August 4, 2015
CompletedJuly 30, 2021
July 1, 2021
1.8 years
September 12, 2012
June 9, 2015
July 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\<LLOQ\]) 12 weeks after the last dose of study drug.
12 weeks after the last actual dose of study drug
Secondary Outcomes (4)
Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment
24 weeks after the last actual dose of study drug
Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.
Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8
Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.
Within 12 weeks after the last dose of study drug
Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events
From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.
Study Arms (8)
Group 1
EXPERIMENTALABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
Group 2
EXPERIMENTALABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
Group 3
EXPERIMENTALABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
Group 4
EXPERIMENTALABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
Group 5
EXPERIMENTALABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-experienced, HCV GT4-infected participants
Group 6
EXPERIMENTALABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
Group 7
EXPERIMENTALABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
Group 8
EXPERIMENTALABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
Interventions
Eligibility Criteria
You may qualify if:
- Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile
- Subjects must meet one of the following:
- Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR
- Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegIFN/RBV);
- Body mass index (BMI) is ≥ 18 to \< 38 kg/m\^2.
- Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.
- Subject has plasma HCV RNA level \> 10,000 IU/mL at Screening
You may not qualify if:
- History of severe, life-threatening or other significant sensitivity to any drug.
- Females who were pregnant or planned to become pregnant, or breastfeeding, or GT4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug/RBV.
- Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
- Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency Virus (HIV) antibodies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Hezode C, Asselah T, Reddy KR, Hassanein T, Berenguer M, Fleischer-Stepniewska K, Marcellin P, Hall C, Schnell G, Pilot-Matias T, Mobashery N, Redman R, Vilchez RA, Pol S. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet. 2015 Jun 20;385(9986):2502-9. doi: 10.1016/S0140-6736(15)60159-3. Epub 2015 Mar 31.
PMID: 25837829BACKGROUNDLawitz E, Makara M, Akarca US, Thuluvath PJ, Preotescu LL, Varunok P, Morillas RM, Hall C, Mobashery N, Redman R, Pilot-Matias T, Vilchez RA, Hezode C. Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-Label Study of Patients With Genotype 1b Chronic Hepatitis C Virus Infection With and Without Cirrhosis. Gastroenterology. 2015 Oct;149(4):971-80.e1. doi: 10.1053/j.gastro.2015.07.001. Epub 2015 Jul 11.
PMID: 26170136BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Information
- Organization
- AbbVie (prior sponsor, Abbott)
Study Officials
- STUDY DIRECTOR
Nilou Mobashery, MD
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2012
First Posted
September 14, 2012
Study Start
August 1, 2012
Primary Completion
June 1, 2014
Study Completion
February 1, 2015
Last Updated
July 30, 2021
Results First Posted
August 4, 2015
Record last verified: 2021-07