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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

NCT ID: NCT01842451

Last Updated: 2015-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Hepatitis C CHC HCV Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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VX-135 High Dose with Daclatasvir

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

Group Type EXPERIMENTAL

VX-135

Intervention Type DRUG

Daclatasvir

Intervention Type DRUG

VX-135 Low Dose with Daclatasvir

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

Group Type EXPERIMENTAL

VX-135

Intervention Type DRUG

Daclatasvir

Intervention Type DRUG

Interventions

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VX-135

Intervention Type DRUG

Daclatasvir

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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New Zealand

Auckland, , New Zealand

Site Status

New Zealand

Christchurch, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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VX13-135-105

Identifier Type: -

Identifier Source: org_study_id