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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

Primary Purpose

Chronic Hepatitis C, CHC, HCV

Status
Completed
Phase
Phase 2
Locations
New Zealand
Study Type
Interventional
Intervention
VX-135
Daclatasvir
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New Zealand
  • New Zealand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

VX-135 High Dose with Daclatasvir

VX-135 Low Dose with Daclatasvir

Arm Description

12 weeks of a high dose of VX-135 in combination with Daclatasvir

12 weeks of a low dose of VX-135 in combination with Daclatasvir

Outcomes

Primary Outcome Measures

The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments

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)
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24)
The proportion of subjects who have virologic relapse
The proportion of subjects who have virologic breakthrough
The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure
The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)

Full Information

First Posted
April 24, 2013
Last Updated
November 30, 2015
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01842451
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, CHC, HCV, Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VX-135 High Dose with Daclatasvir
Arm Type
Experimental
Arm Description
12 weeks of a high dose of VX-135 in combination with Daclatasvir
Arm Title
VX-135 Low Dose with Daclatasvir
Arm Type
Experimental
Arm Description
12 weeks of a low dose of VX-135 in combination with Daclatasvir
Intervention Type
Drug
Intervention Name(s)
VX-135
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
The proportion of subjects who have virologic relapse
Time Frame
Up to 64 weeks
Title
The proportion of subjects who have virologic breakthrough
Time Frame
Up to 16 weeks
Title
The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure
Time Frame
Up to 64 weeks
Title
The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)
Time Frame
Up to 28 weeks
Title
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
Time Frame
Up to 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
New Zealand
City
Auckland
Country
New Zealand
Facility Name
New Zealand
City
Christchurch
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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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