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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2018 |
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Main ID: |
NCT01790100 |
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Date of registration:
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11/02/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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A Randomized, Phase 2a, Partially-Blind, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C |
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Date of first enrolment:
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February 28, 2013 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01790100 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Moldova, Republic of
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Subjects (male and female) must be between 18-60 years of age
- 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
Key Exclusion Criteria:
- Evidence of cirrhosis
- 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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis C
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Intervention(s)
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Drug: VX-135
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Drug: Ribavirin
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Primary Outcome(s)
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Safety
[Time Frame: Week 12]
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Secondary Outcome(s)
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evidence of HCV RNA viral load reduction
[Time Frame: 16 weeks]
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Secondary ID(s)
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2012-005633-37
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ALS-135-101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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