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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

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ClinicalTrials.gov Identifier: NCT01842451
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C CHC HCV Hepatitis C Drug: VX-135 Drug: Daclatasvir Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Daclatasvir
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. The proportion of subjects who have virologic relapse [ Time Frame: Up to 64 weeks ]
  5. The proportion of subjects who have virologic breakthrough [ Time Frame: Up to 16 weeks ]
  6. The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure [ Time Frame: Up to 64 weeks ]
  7. The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a) [ Time Frame: Up to 28 weeks ]
  8. The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC) [ Time Frame: Up to 28 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842451


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

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01842451     History of Changes
Other Study ID Numbers: VX13-135-105
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: November 2015

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