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

Vertex Pharmaceuticals Incorporated23 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Hepatitis C CHC HCV Hepatitis C

Interventions

VX-135DRUG

DaclatasvirDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

New Zealand

Auckland, New Zealand

New Zealand

Christchurch, New Zealand

Outcomes

Primary Outcomes

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 Outcomes

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

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

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

The proportion of subjects who have virologic relapse

Time frame: Up to 64 weeks

The proportion of subjects who have virologic breakthrough

Time frame: 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

The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.