Hepatitis C Clinical Trial
Official title:
A Phase 2, Multicenter, Randomized, Partially-Blind, Dose-Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
Verified date | November 2015 |
Source | Vertex Pharmaceuticals Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | New Zealand: Medsafe |
Study type | Interventional |
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
Status | Completed |
Enrollment | 23 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Subjects must have genotype 1 CHC and evidence of HCV infection at least 6 months before screening - Subjects must be treatment-naïve and have not received prior treatment with any interferon, immunomodulatory agent, or DAA for HCV Exclusion Criteria: - Evidence of cirrhosis - History or other clinical evidence of significant or unstable cardiac disease - Any other cause of significant liver disease in addition to hepatitis C - Creatinine clearance =50 mL/min using the Cockcroft-Gault equation at screening - Female subjects who are pregnant or nursing |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
New Zealand | New Zealand | Auckland | |
New Zealand | New Zealand | Christchurch |
Lead Sponsor | Collaborator |
---|---|
Vertex Pharmaceuticals Incorporated |
New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments | Up to 64 weeks | Yes | |
Secondary | The proportion of subjects who have a sustained virologic response (SVR; i.e., HCV RNA concentration below the lower limit of quantitation [<LLOQ; <25 IU/mL]) at 4 weeks after the last planned dose of treatment (SVR4) | Up to 20 Weeks | No | |
Secondary | The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12) | Up to 28 weeks | No | |
Secondary | The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24) | Up to 40 weeks | No | |
Secondary | The proportion of subjects who have virologic relapse | Up to 64 weeks | No | |
Secondary | The proportion of subjects who have virologic breakthrough | Up to 16 weeks | No | |
Secondary | The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure | Up to 64 weeks | No | |
Secondary | The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a) | Up to 28 weeks | No | |
Secondary | The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC) | Up to 28 weeks | No |
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