A Phase 2a, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
NCT ID: NCT01790100
Last Updated: 2017-12-18
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
20 participants
INTERVENTIONAL
2013-02-28
2014-06-30
Brief Summary
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Detailed Description
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Safety and tolerability will be evaluated on an ongoing basis through assessment of adverse events (AEs), lab evaluations and physical examinations. Subjects will be monitored from Day 1 through end of follow-up for virologic breakthrough or relapse.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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VX-135 low dose in combination with ribavirin
12 weeks of VX-135 in combination with ribavirin
VX-135
12 weeks of VX-135
Ribavirin
12 weeks of ribavirin
VX-135 high dose in combination with ribavirin
VX-135
12 weeks of VX-135
Ribavirin
12 weeks of ribavirin
Interventions
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VX-135
12 weeks of VX-135
Ribavirin
12 weeks of ribavirin
Eligibility Criteria
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Inclusion Criteria
* Subjects must have Chronic Hepatitis C
* Subjects must be treatment naive
* Subjects must have laboratory values at screening within limits as specified by the protocol
Exclusion Criteria
* Female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study
* any other cause of significant liver disease in addition to hepatitis C
* Diagnosis of or suspected hepatocellular carcinoma
18 Years
60 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Alios Biopharma Inc.
INDUSTRY
Responsible Party
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Locations
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Arensia, Republican Clinical Hospital
Chisinau, , Moldova
Countries
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Other Identifiers
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2012-005633-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALS-135-101
Identifier Type: -
Identifier Source: org_study_id