A Phase 2 interventional study of VX-135 and Daclatasvir in Chronic Hepatitis C, CHC and HCV, sponsored by Vertex Pharmaceuticals Incorporated. Completed at 2 sites in New Zealand. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-12-29.
Sponsored by Vertex Pharmaceuticals Incorporated · Phase 2, Interventional, and Treatment
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
1,090 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.
This study's enrollment of 23 is below the median of 90 across 789 interventional studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →Vertex Pharmaceuticals Incorporated is the lead sponsor of 249 studies on the registry; 20 are open to participants now.
Of its 106 completed or terminated interventional studies of FDA-regulated products, 53 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
12 weeks of a high dose of VX-135 in combination with Daclatasvir
Drug: VX-135 · Drug: Daclatasvir
12 weeks of a low dose of VX-135 in combination with Daclatasvir
Drug: VX-135 · Drug: Daclatasvir
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments
Time frame: Up to 64 weeks
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)
Time frame: Up to 20 Weeks
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
Time frame: Up to 28 weeks
The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24)
Time frame: Up to 40 weeks
The proportion of subjects who have virologic relapse
Time frame: Up to 64 weeks
The proportion of subjects who have virologic breakthrough
Time frame: Up to 16 weeks
The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure
Time frame: Up to 64 weeks
The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)
Time frame: Up to 28 weeks
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
Time frame: Up to 28 weeks
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: VX-135 · Daclatasvir
Vertex Pharmaceuticals Incorporated →