A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)
NCT ID: NCT01221298
Last Updated: 2015-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
11 participants
INTERVENTIONAL
2010-10-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ABT-450/r and ABT-072, plus ribavirin (RBV)
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
ABT-450
tablets
ABT-072
tablets
Ribavirin
tablets
Ritonavir
capsules
Interventions
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ABT-450
tablets
ABT-072
tablets
Ribavirin
tablets
Ritonavir
capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) - induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.
* Treatment naïve male or female between the ages of 18 and 65.
* Females must be postmenopausal for at least 2 years or surgically sterile.
* Be in a condition of general good health, as perceived by the investigator, other than hepatitis C virus infection.
* Body mass index 18 to \< 35 kg/m\^2 .
Exclusion Criteria
* Use of herbal supplements within 2 weeks prior to study drug dosing.
* Positive screen for certain drugs or alcohol.
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibody.
* Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing.
* Prior treatment with any investigational or commercially available anti-hepatitis C virus agents.
* Abnormal laboratory tests.
* Cirrhosis or extensive bridging fibrosis.
* History of cardiac disease.
18 Years
65 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Cohen, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 41128
Los Angeles, California, United States
Site Reference ID/Investigator# 42262
Chicago, Illinois, United States
Site Reference ID/Investigator# 41127
San Antonio, Texas, United States
Site Reference ID/Investigator# 43182
Seattle, Washington, United States
Countries
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References
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Lawitz E, Poordad F, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, Larsen L, Menon R, Koev G, Tripathi R, Pilot-Matias T, Bernstein B. A phase 2a trial of 12-week interferon-free therapy with two direct-acting antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C genotype 1. J Hepatol. 2013 Jul;59(1):18-23. doi: 10.1016/j.jhep.2013.02.009. Epub 2013 Feb 22.
Related Links
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Related Info
Other Identifiers
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M12-267
Identifier Type: -
Identifier Source: org_study_id
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