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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01842451
Other study ID # VX13-135-105
Secondary ID
Status Completed
Phase Phase 2
First received April 24, 2013
Last updated November 30, 2015
Start date June 2013
Est. completion date May 2014

Study information

Verified date November 2015
Source Vertex Pharmaceuticals Incorporated
Contact n/a
Is FDA regulated No
Health authority New Zealand: Medsafe
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
VX-135

Daclatasvir


Locations

Country Name City State
New Zealand New Zealand Auckland
New Zealand New Zealand Christchurch

Sponsors (1)

Lead Sponsor Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments Up to 64 weeks Yes
Secondary 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 No
Secondary The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12) Up to 28 weeks No
Secondary The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24) Up to 40 weeks No
Secondary The proportion of subjects who have virologic relapse Up to 64 weeks No
Secondary The proportion of subjects who have virologic breakthrough Up to 16 weeks No
Secondary The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure Up to 64 weeks No
Secondary The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a) Up to 28 weeks No
Secondary The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC) Up to 28 weeks No
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