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 C

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842451
• Other study ID #: VX13-135-105
• 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

Related Conditions & MeSH terms

• CHC
• Chronic Hepatitis C
• HCV
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

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