A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults
NCT ID: NCT01715415
Last Updated: 2021-08-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
395 participants
INTERVENTIONAL
2012-11-30
2014-10-31
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
DOUBLE
Study Groups
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ABT-450/r/ABT-267 and ABT-333, plus RBV
Double-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
ABT-450/r/ABT-267, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Ribavirin
Capsule (double-blind treatment period), tablet (open-label treatment period)
Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
Double-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
ABT-450/r/ABT-267, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Ribavirin
Capsule (double-blind treatment period), tablet (open-label treatment period)
Placebo for ABT-450/r/ABT-267
Tablet
Placebo for ABT-333
Tablet
Placebo for ribavirin
Capsule
Interventions
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ABT-450/r/ABT-267, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Ribavirin
Capsule (double-blind treatment period), tablet (open-label treatment period)
Placebo for ABT-450/r/ABT-267
Tablet
Placebo for ABT-333
Tablet
Placebo for ribavirin
Capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
70 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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Jeff Enejosa, MD
Role: STUDY_DIRECTOR
AbbVie
References
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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.
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.
Related Links
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Related Info
Other Identifiers
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2012-002035-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M13-098
Identifier Type: -
Identifier Source: org_study_id
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