NCT01726946CompletedPhase 2
A Phase 2, Multicenter, Dose-Ranging Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
Vertex Pharmaceuticals Incorporated5 sites in 1 country10 target enrollmentStarted: November 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 10
- Locations
- 5
- Primary Endpoint
- The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments
Study Overview
Brief Summary
A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135 in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects (male and female) must be between the ages of 18 and 60 years at screening
- •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
- •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
- •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
Arms & Interventions
VX-135 Low Dose with ribavirin
Experimental
12 weeks of a low dose of VX-135 in combination with ribavirin
Intervention: ribavirin (Drug)
VX-135 High Dose with ribavirin
Experimental
12 weeks of a high dose of VX-135 in combination with ribavirin
Intervention: VX-135 (Drug)
VX-135 High Dose with ribavirin
Experimental
12 weeks of a high dose of VX-135 in combination with ribavirin
Intervention: ribavirin (Drug)
VX-135 Low Dose with ribavirin
Experimental
12 weeks of a low dose of VX-135 in combination with ribavirin
Intervention: VX-135 (Drug)
Outcomes
Primary Outcomes
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments
Time Frame: Up to 52 weeks
Secondary Outcomes
- The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)(16 weeks)
- The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)(24 weeks)
- The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)(36 weeks)
- The proportion of subjects who have virologic relapse(Up to 52 weeks)
- Viral kinetics, as determined at different time points by the proportion of subjects who achieve: -Undetectable HCV RNA -<LLOQ HCV RNA(Up to 64 weeks)
- The proportion of subjects who have virologic breakthrough(Up to 52 weeks)
- The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)(up to 28 weeks)
- The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment(Up to 60 weeks)
Investigators
Study Sites (5)
Loading locations...
Similar Trials
Completed
Phase 2
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 CChronic Hepatitis CCHCHCVHepatitis CNCT01842451Vertex Pharmaceuticals Incorporated23
Completed
Phase 2
Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT01284387JANSSEN Alzheimer Immunotherapy Research & Development, LLC126
Completed
Phase 2
Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702Rheumatoid ArthritisNCT00205478Vertex Pharmaceuticals Incorporated300
Completed
Phase 2
Study of Lenalidomide to Evaluate Safety and Efficacy in Patients With Relapsed or Refractory Chronic Lymphocytic LeukemiaRelapsed or Refractory Chronic Lymphocytic LeukemiaNCT00963105Celgene104
Completed
Phase 1
A Dose Ranging Study to Evaluate the Safety and Potential Efficacy of rhNGF in Patients With Retinitis Pigmentosa (RP)Retinitis PigmentosaNCT02110225Dompé Farmaceutici S.p.A50