A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before
NCT ID: NCT01854697
Last Updated: 2018-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
311 participants
INTERVENTIONAL
2013-03-31
2015-07-31
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 A: 3-DAA + RBV in GT1a
ABT-450/r/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based RBV for 12 weeks (3 direct-acting antivirals \[DAAs\] with RBV in GT1a)
ABT-450/r/ABT-267, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Ribavirin
Tablet
Arm B: TPV/PR in GT1a
Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegIFN 180 µg/week and weight-based RBV (PR) for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
Ribavirin
Tablet
Telaprevir
Film-coated tablet
Pegylated Interferon alpha 2-a (PegIFN)
Pre-filled syringe
Arm C: 3-DAA + RBV in GT1b
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
ABT-450/r/ABT-267, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Ribavirin
Tablet
Arm D: 3-DAA in GT1b
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
ABT-450/r/ABT-267, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Arm E: TPV/PR in GT1b
Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Ribavirin
Tablet
Telaprevir
Film-coated tablet
Pegylated Interferon alpha 2-a (PegIFN)
Pre-filled syringe
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
Tablet
Telaprevir
Film-coated tablet
Pegylated Interferon alpha 2-a (PegIFN)
Pre-filled syringe
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control
* Subject has never received antiviral treatment for hepatitis C infection
* Chronic HCV Genotype-1 infection prior to study enrollment
Exclusion Criteria
* Females who are pregnant or plan to become pregnant, or breastfeeding
* Any current or past clinical evidence of cirrhosis
* Screening laboratory analyses that showing abnormal laboratory results
* Use of contraindicated medications within 2 weeks of dosing and subject with contraindication for telaprevir, pegIFN and RBV
* Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol
* Positive screen for drugs or alcohol
18 Years
65 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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Yan Luo, MD, PhD
Role: STUDY_DIRECTOR
AbbVie
References
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Dore GJ, Conway B, Luo Y, Janczewska E, Knysz B, Liu Y, Streinu-Cercel A, Caruntu FA, Curescu M, Skoien R, Ghesquiere W, Mazur W, Soza A, Fuster F, Greenbloom S, Motoc A, Arama V, Shaw D, Tornai I, Sasadeusz J, Dalgard O, Sullivan D, Liu X, Kapoor M, Campbell A, Podsadecki T. Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials. J Hepatol. 2016 Jan;64(1):19-28. doi: 10.1016/j.jhep.2015.08.015. Epub 2015 Aug 29.
Related Links
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Related Info
Other Identifiers
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2012-003754-84
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M13-774
Identifier Type: -
Identifier Source: org_study_id
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