A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C

Vertex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: VX-135; Drug: ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01726946

VX12-135-101

Details and patient eligibility

About

A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135 in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subjects (male and female) must be between the ages of 18 and 60 years at screening
• Subjects must have genotype 1 Chronic Hepatitis C
• Subjects must be treatment naïve
• Subjects must have laboratory values at screening within limits as specified by the protocol

Key Exclusion Criteria:

• Evidence of cirrhosis
• Female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study
• Any other cause of significant liver disease in addition to hepatitis C
• Human immunodeficiency virus -1 or -2
• Diagnosis of or suspected hepatocellular carcinoma
• History of organ transplant, with the exception of corneal transplants and skin grafts

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups

VX-135 High Dose with ribavirin

Experimental group

Description:

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

Treatment:

Drug: VX-135

Drug: ribavirin

VX-135 Low Dose with ribavirin

Experimental group

Description:

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

Treatment:

Drug: VX-135

Drug: ribavirin