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

Status and phase: Completed; Phase 2

Conditions: CHC; Hepatitis C; HCV; Chronic Hepatitis C

Treatments: Drug: VX-135; Drug: Daclatasvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01842451

VX13-135-105

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups

VX-135 High Dose with Daclatasvir

Experimental group

Description:

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

Treatment:

Drug: Daclatasvir

Drug: VX-135

VX-135 Low Dose with Daclatasvir

Experimental group

Description:

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

Treatment:

Drug: Daclatasvir

Drug: VX-135