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

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726946
• Other study ID #: VX12-135-101
• Status: Completed
• Phase: Phase 2
• First received: November 7, 2012
• Last updated: March 27, 2015
• Start date: November 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• VX-135
12 weeks of VX-135
• ribavirin
12 weeks of ribavirin

Locations

Country	Name	City	State
United States	Texas	Arlington	Texas
United States	Tennessee	Germantown	Tennessee
United States	Texas	Houston	Texas
United States	California	La Jolla	California
United States	Georgia	Marietta	Georgia
United States	Florida	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments		Up to 52 weeks	Yes
Secondary	The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)		16 weeks	No
Secondary	The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)		24 weeks	No
Secondary	The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)		36 weeks	No
Secondary	The proportion of subjects who have virologic relapse		Up to 52 weeks	No
Secondary	Viral kinetics, as determined at different time points by the proportion of subjects who achieve: -Undetectable HCV RNA -<LLOQ HCV RNA		Up to 64 weeks	No
Secondary	The proportion of subjects who have virologic breakthrough	as measured by on-treatment HCV RNA values	Up to 52 weeks	No
Secondary	The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)		up to 28 weeks	No
Secondary	The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment		Up to 60 weeks	No