Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
NCT ID: NCT02765490
Last Updated: 2019-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
365 participants
INTERVENTIONAL
2016-11-09
2017-11-16
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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Group A
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks.
AL-335
AL-335 800 mg (2\*400) tablet will be administered once daily.
Odalasvir
Odalasvir 25 mg tablet will be administered once daily.
Simeprevir
Simeprevir 75 mg capsule will be administered once daily.
Group B
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks.
AL-335
AL-335 800 mg (2\*400) tablet will be administered once daily.
Odalasvir
Odalasvir 25 mg tablet will be administered once daily.
Simeprevir
Simeprevir 75 mg capsule will be administered once daily.
Interventions
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AL-335
AL-335 800 mg (2\*400) tablet will be administered once daily.
Odalasvir
Odalasvir 25 mg tablet will be administered once daily.
Simeprevir
Simeprevir 75 mg capsule will be administered once daily.
Eligibility Criteria
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Inclusion Criteria
* Documented as treatment naive or experienced with a prior regimen consisting of Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response
* Absence of cirrhosis
* Screening laboratory values within defined thresholds
* Must use specific contraceptive methods if female of childbearing potential or sexually active male
Exclusion Criteria
* Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination with pegylated interferon (PegIFN) or IFN-free
* Current or prior history of clinical hepatic decompensation
* History of clinically significant illness or any other medical disorder including cardiovascular conditions that may interfere with individual's treatment, assessment or compliance with the protocol
* Pregnant or a nursing female
18 Years
70 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Antwerp, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Kortrijik, , Belgium
Leuven, , Belgium
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Toronto, Ontario, Canada
Vaughan, Ontario, Canada
Monteral, Quebec, Canada
Montreal, Quebec, Canada
Berlin, , Germany
Essen, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Leipzig, , Germany
Lodz, , Poland
Lublin, , Poland
Mysłowice, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Singapore, , Singapore
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Seville, , Spain
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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64294178HPC2001
Identifier Type: OTHER
Identifier Source: secondary_id
2015-004200-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR108070
Identifier Type: -
Identifier Source: org_study_id
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