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

November 30, 2015 updated by: Vertex Pharmaceuticals Incorporated

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • New Zealand
      • Christchurch, New Zealand
        • New Zealand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VX-135 High Dose with Daclatasvir
12 weeks of a high dose of VX-135 in combination with Daclatasvir
Drug: Daclatasvir
Drug: VX-135
Experimental: VX-135 Low Dose with Daclatasvir
12 weeks of a low dose of VX-135 in combination with Daclatasvir
Drug: Daclatasvir
Drug: VX-135

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 64 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Up to 20 Weeks
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
Up to 28 weeks
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
Up to 40 weeks
The proportion of subjects who have virologic relapse
Time Frame: Up to 64 weeks
Up to 64 weeks
The proportion of subjects who have virologic breakthrough
Time Frame: Up to 16 weeks
Up to 16 weeks
The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure
Time Frame: Up to 64 weeks
Up to 64 weeks
The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)
Time Frame: Up to 28 weeks
Up to 28 weeks
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
Time Frame: Up to 28 weeks
Up to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimate)

April 29, 2013

Study Record Updates

Last Update Posted (Estimate)

December 29, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX13-135-105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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