Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014