A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Experienced Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-II)
2 other identifiers
interventional
395
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 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
First Submitted
Initial submission to the registry
October 25, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
January 6, 2015
CompletedAugust 2, 2021
July 1, 2021
1 year
October 25, 2012
December 23, 2014
July 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virologic Response 12 Weeks After 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 active study drug
Secondary Outcomes (5)
Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period
At 12 weeks
Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
12 weeks after the last actual dose of active study drug
Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
12 weeks after the last actual dose of active study drug
Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
12 weeks after the last actual dose of active study drug
Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
Within 12 weeks post-treatment
Study Arms (2)
ABT-450/r/ABT-267 and ABT-333, plus RBV
EXPERIMENTALDouble-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
EXPERIMENTALDouble-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Interventions
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Capsule (double-blind treatment period), tablet (open-label treatment period)
Eligibility Criteria
You may qualify if:
- Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control.
- Chronic hepatitis C, genotype 1 infection and HCV RNA level greater than 10,000 IU/mL at screening.
- Previous treatment failure of peg-interferon and ribavirin (pegIFN and RBV).
- No evidence of liver cirrhosis.
You may not qualify if:
- Positive screen for drugs or alcohol.
- Significant sensitivity to any drug.
- Use of contraindicated medications within 2 weeks of dosing.
- Certain predefined abnormal laboratory tests.
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourliere M, Sulkowski MS, Wedemeyer H, Tam E, Desmond P, Jensen DM, Di Bisceglie AM, Varunok P, Hassanein T, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24;370(17):1604-14. doi: 10.1056/NEJMoa1401561. Epub 2014 Apr 10.
PMID: 24720679RESULTFeld 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.
PMID: 29377566DERIVED
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
Jeff Enejosa, MD
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2012
First Posted
October 29, 2012
Study Start
November 1, 2012
Primary Completion
November 1, 2013
Study Completion
October 1, 2014
Last Updated
August 2, 2021
Results First Posted
January 6, 2015
Record last verified: 2021-07