A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
NCT ID: NCT01726946
Last Updated: 2015-04-16
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
10 participants
INTERVENTIONAL
2012-11-30
2014-02-28
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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VX-135 High Dose with ribavirin
12 weeks of a high dose of VX-135 in combination with ribavirin
VX-135
12 weeks of VX-135
ribavirin
12 weeks of ribavirin
VX-135 Low Dose with ribavirin
12 weeks of a low dose of VX-135 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 genotype 1 Chronic Hepatitis C
* Subjects must be treatment naïve
* 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
* Human immunodeficiency virus -1 or -2
* Diagnosis of or suspected hepatocellular carcinoma
* History of organ transplant, with the exception of corneal transplants and skin grafts
18 Years
60 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
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California
La Jolla, California, United States
Florida
Orlando, Florida, United States
Georgia
Marietta, Georgia, United States
Tennessee
Germantown, Tennessee, United States
Texas
Arlington, Texas, United States
Texas
Houston, Texas, United States
Countries
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Other Identifiers
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VX12-135-101
Identifier Type: -
Identifier Source: org_study_id
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