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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01842451
First received: April 24, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Chronic Hepatitis C
CHC
HCV
Hepatitis C
Drug: VX-135
Drug: Daclatasvir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The proportion of subjects who have virologic relapse [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who have virologic breakthrough [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
  • The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure [ Time Frame: Up to 64 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a) [ Time Frame: Up to 28 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC) [ Time Frame: Up to 28 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VX-135 High Dose with Daclatasvir
12 weeks of a high dose of VX-135 in combination with Daclatasvir
Drug: VX-135 Drug: Daclatasvir
Experimental: VX-135 Low Dose with Daclatasvir
12 weeks of a low dose of VX-135 in combination with Daclatasvir
Drug: VX-135 Drug: Daclatasvir

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01842451

Locations
New Zealand
New Zealand
Auckland, New Zealand
New Zealand
Christchurch, New Zealand
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01842451     History of Changes
Other Study ID Numbers: VX13-135-105
Study First Received: April 24, 2013
Last Updated: April 2, 2014
Health Authority: New Zealand: Medsafe

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 21, 2014