A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection
NCT ID: NCT02593162
Last Updated: 2017-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2015-10-31
2016-12-31
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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Group 1
12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin
Faldaprevir
TD-6450
Ribavirin
Group 2
12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin
Faldaprevir
TD-6450
Ribavirin
Interventions
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Faldaprevir
TD-6450
Ribavirin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hepatitis C virus treatment naive, defined as defined as having never received a direct acting anti-viral (DAA), and as having received ≤ 8 weeks of interferon ≥ 6 months prior to screening
* Absence of cirrhosis as defined by one of the following:
* A liver biopsy performed within 24 calendar months of Day 1 showing absence of cirrhosis
* Transient elastography (FibroScan®) performed within 12 calendar months of Day 1 with a result of ≤ 12.5 kPa
* A FibroSure® score ≤ 0.48 and AST:platelet ratio (APRI) ≤ 1 performed during screening
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Trek Therapeutics, PBC
INDUSTRY
Responsible Party
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Principal Investigators
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Tarek Hassanein, MD
Role: PRINCIPAL_INVESTIGATOR
Southern California Research Center
Locations
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Southern California Research Center
Coronado, California, United States
Countries
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Other Identifiers
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TRK-450-0201
Identifier Type: -
Identifier Source: org_study_id
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