Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01842451
NCT01842451CompletedPhase 2

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

Vertex Pharmaceuticals Incorporated1 site in 1 country23 target enrollmentStarted: June 2013Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
23
Locations
1
Primary Endpoint
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

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 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

Arms & Interventions

VX-135 High Dose with Daclatasvir

Experimental

12 weeks of a high dose of VX-135 in combination with Daclatasvir

Intervention: VX-135 (Drug)

VX-135 High Dose with Daclatasvir

Experimental

12 weeks of a high dose of VX-135 in combination with Daclatasvir

Intervention: Daclatasvir (Drug)

VX-135 Low Dose with Daclatasvir

Experimental

12 weeks of a low dose of VX-135 in combination with Daclatasvir

Intervention: VX-135 (Drug)

VX-135 Low Dose with Daclatasvir

Experimental

12 weeks of a low dose of VX-135 in combination with Daclatasvir

Intervention: Daclatasvir (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24)(Up to 40 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)(Up to 20 Weeks)
  • The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)(Up to 28 weeks)
  • The proportion of subjects who have virologic breakthrough(Up to 16 weeks)
  • The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure(Up to 64 weeks)
  • The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)(Up to 28 weeks)
  • The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)(Up to 28 weeks)
  • The proportion of subjects who have virologic relapse(Up to 64 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 2
Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental GlomerulosclerosisGlomerulosclerosis, Focal Segmental
NCT04340362Vertex Pharmaceuticals Incorporated16
Completed
Phase 2
A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis CChronic Hepatitis C
NCT01726946Vertex Pharmaceuticals Incorporated10
Completed
Phase 2
Study of VX-765 in Subjects With Treatment-resistant Partial EpilepsyPartial Epilepsy
NCT01048255Vertex Pharmaceuticals Incorporated60
Completed
Phase 1
A Study to Evaluate the Effect of Food on the Pharmacokinetics of VX-548Pain
NCT05851157Vertex Pharmaceuticals Incorporated73
Completed
Phase 2
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a BunionectomyAcute Pain
NCT04977336Vertex Pharmaceuticals Incorporated274
A Phase 2 Study to Evaluate the Safety,... | Clinical Trial