Status:
COMPLETED
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Chronic Hepatitis C
CHC
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01842451
Start Date
June 1 2013
End Date
May 1 2014
Last Update
December 29 2015
Active Locations (2)
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1
New Zealand
Auckland, New Zealand
2
New Zealand
Christchurch, New Zealand