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

Phase 2

Completed

• Conditions: Chronic Hepatitis C; HCV; Hepatitis C; CHC
• Interventions: Drug: VX-135; Drug: Daclatasvir

• Registration Number: NCT01842451
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-29
• Study Start: 2013-06
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Disposition First Submitted: 2015-10-23
• Disposition First Submitted QC: 2015-10-23
• Status Verified: 2015-11
• Disposition First Posted: 2015-11-20
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VX-135 High Dose with Daclatasvir	VX-135	12 weeks of a high dose of VX-135 in combination with Daclatasvir
VX-135 High Dose with Daclatasvir	Daclatasvir	12 weeks of a high dose of VX-135 in combination with Daclatasvir
VX-135 Low Dose with Daclatasvir	VX-135	12 weeks of a low dose of VX-135 in combination with Daclatasvir
VX-135 Low Dose with Daclatasvir	Daclatasvir	12 weeks of a low dose of VX-135 in combination with Daclatasvir

Primary Outcome Measures

Name	Time	Method
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments	Up to 64 weeks

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24)	Up to 40 weeks
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)	Up to 20 Weeks
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)	Up to 28 weeks
The proportion of subjects who have virologic breakthrough	Up to 16 weeks
The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure	Up to 64 weeks
The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)	Up to 28 weeks
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)	Up to 28 weeks
The proportion of subjects who have virologic relapse	Up to 64 weeks

Trial Locations

Locations (1)

New Zealand; 🇳🇿 Christchurch, New Zealand