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

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790100
• Other study ID #: ALS-135-101
• Secondary ID: 2012-005633-37
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2013
• Last updated: December 14, 2017
• Start date: February 28, 2013
• Est. completion date: June 30, 2014

Study information

• Verified date: December 2017
• Source: Alios Biopharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C infection.

Description:

Up to twenty (20) subjects with CHC GT1 infection will be randomized in a 1:1 ratio (with stratification by IL-28B genotype (CC versus non-CC)) to evaluate VX-135 low dose or high dose both given in combination with RBV for 12 weeks.

Safety and tolerability will be evaluated on an ongoing basis through assessment of adverse events (AEs), lab evaluations and physical examinations. Subjects will be monitored from Day 1 through end of follow-up for virologic breakthrough or relapse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2014
• Est. primary completion date: June 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Key Inclusion Criteria:

• Subjects (male and female) must be between 18-60 years of age

• Subjects must have Chronic Hepatitis C

• Subjects must be treatment naive

• 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

• Diagnosis of or suspected hepatocellular carcinoma

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
Moldova, Republic of	Arensia, Republican Clinical Hospital	Chisinau

Sponsors (2)

Lead Sponsor	Collaborator
Alios Biopharma Inc.	Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	The safety and tolerability as assessed by evaluating adverse events and laboratory testing.	Week 12
Secondary	evidence of HCV RNA viral load reduction	The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)	16 weeks