A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection
NCT ID: NCT01672983
Last Updated: 2018-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2012-07-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Arm 2
Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Arm 3
Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Arm 4
Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Arm 5
Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Arm 6
Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Interventions
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ABT-450/ritonavir, ABT-267
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic hepatitis C, genotype 1b (HCV-GT1b) or genotype 2 (HCV GT2) infection (HCV RNA level greater than 10,000 IU/mL at screening) previously treated with pegylated interferon/ribavirin (pegIFN/RBV).
* Subject's hepatitis C virus genotype is subgenotype 1b and subject was a null responder or partial responder, OR
* Subject's hepatitis C virus genotype is subgenotype 2 and subject was a null responder, partial responder, or relapser (Null responder: received at least 10 weeks of pegIFN/RBV for the treatment of HCV and failed to achieve a 2 log10 IU/mL reduction in HCV RNA at Week 12; Partial responders: received at least 20 weeks of pegIFN/RBV for the treatment of HCV and achieved ≥ 2 log10 IU/mL reduction in HCV RNA at Week 12, but failed to achieve HCV RNA undetectable (HCV RNA \< lower limit of detection \[\< LLOD\]) at the end of treatment; Relapsers: received at least 1 course of pegIFN/RBV for the treatment of HCV and was undetectable at the end of treatment, but HCV RNA was detectable within 24 weeks of treatment follow-up).
Exclusion Criteria
* Positive screen for drugs or alcohol.
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.
* Use of contraindicated medications within 2 weeks of dosing
* Previous use of any investigational or commercially available anti-Hepatitis C virus agent other than pegIFN/RBV, including previous exposure to ABT-450 or ABT-267.
18 Years
75 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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Takuma Matsuda, MS
Role: STUDY_DIRECTOR
AbbVie
References
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Chayama K, Notsumata K, Kurosaki M, Sato K, Rodrigues L Jr, Setze C, Badri P, Pilot-Matias T, Vilchez RA, Kumada H. Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients. Hepatology. 2015 May;61(5):1523-32. doi: 10.1002/hep.27705. Epub 2015 Mar 23.
Schnell G, Tripathi R, Krishnan P, Beyer J, Reisch T, Irvin M, Dekhtyar T, Setze C, Rodrigues L Jr, Alves K, Burroughs M, Redman R, Chayama K, Kumada H, Collins C, Pilot-Matias T. Resistance characterization of hepatitis C virus genotype 2 from Japanese patients treated with ombitasvir and paritaprevir/ritonavir. J Med Virol. 2018 Jan;90(1):109-119. doi: 10.1002/jmv.24923. Epub 2017 Sep 22.
Related Links
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Related Info
Other Identifiers
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M12-536
Identifier Type: -
Identifier Source: org_study_id
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