Clinical trial NCT01726946: A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
HCV
CHC
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2012-11-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)
timeFrame: 16 weeks
measure: The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
timeFrame: 24 weeks
measure: The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)
timeFrame: 36 weeks
measure: The proportion of subjects who have virologic relapse
timeFrame: Up to 52 weeks
measure: Viral kinetics, as determined at different time points by the proportion of subjects who achieve: -Undetectable HCV RNA -<LLOQ HCV RNA
timeFrame: Up to 64 weeks
measure: The proportion of subjects who have virologic breakthrough
timeFrame: Up to 52 weeks
measure: The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
timeFrame: up to 28 weeks
measure: The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment
timeFrame: Up to 60 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: California
state: California
city: Orlando
country: United States
facility: Florida
state: Florida
city: Marietta
country: United States
facility: Georgia
state: Georgia
city: Germantown
country: United States
facility: Tennessee
state: Tennessee
city: Arlington
country: United States
facility: Texas
state: Texas
city: Houston
country: United States
facility: Texas
state: Texas
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References: