A Phase 2 interventional study of VX-135 and ribavirin in Chronic Hepatitis C, sponsored by Vertex Pharmaceuticals Incorporated. Completed at 6 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-04-16.
Sponsored by Vertex Pharmaceuticals Incorporated · Phase 2, Interventional, and Treatment
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
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 10 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Vertex Pharmaceuticals Incorporated is the lead sponsor of 243 studies on the registry; 19 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 49 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
12 weeks of a high dose of VX-135 in combination with ribavirin
Drug: VX-135 · Drug: ribavirin
12 weeks of a low dose of VX-135 in combination with ribavirin
Drug: VX-135 · Drug: ribavirin
12 weeks of VX-135
12 weeks of ribavirin
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
The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)
Time frame: 16 weeks
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
Time frame: 24 weeks
The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)
Time frame: 36 weeks
The proportion of subjects who have virologic relapse
Time frame: 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
Time frame: Up to 64 weeks
The proportion of subjects who have virologic breakthrough
as measured by on-treatment HCV RNA values
Time frame: Up to 52 weeks
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
Time frame: up to 28 weeks
The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment
Time frame: Up to 60 weeks
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Vertex Pharmaceuticals Incorporated