A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a Chronic Hepatitis C

Vertex Pharmaceuticals Incorporated0 sites64 target enrollmentJuly 2012

ConditionsChronic Hepatitis C Virus

InterventionsVX-222 telaprevir ribavirin

DrugsVX-222 telaprevir ribavirin

Overview

Phase: Phase 2
Intervention: VX-222
Conditions: Chronic Hepatitis C Virus
Sponsor: Vertex Pharmaceuticals Incorporated
Enrollment: 64
Primary Endpoint: The proportion of subjects who have a sustained viral response (SVR) at 12 weeks after the last planned dose of treatment
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

December 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vertex Pharmaceuticals Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must have genotype 1 chronic hepatitis C (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
•Subjects will be treatment naïve
•Subjects must have documentation of the presence or absence of cirrhosis

Exclusion Criteria

•History or other clinical evidence of significant or unstable cardiac disease
•Evidence of hepatic decompensation
•Diagnosed or suspected hepatocellular carcinoma
•Any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug-or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
•History of organ transplant, with the exception of corneal transplants and skin grafts

Arms & Interventions

12 week treatment

Intervention: VX-222

12 week treatment

Intervention: telaprevir

12 week treatment

Intervention: ribavirin

16 week treatment

Intervention: VX-222

16 week treatment

Intervention: telaprevir

16 week treatment

Intervention: ribavirin

Outcomes

Primary Outcomes

The proportion of subjects who have a sustained viral response (SVR) at 12 weeks after the last planned dose of treatment

Time Frame: 12 weeks after the last planned dose of treatment

Secondary Outcomes

The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12(12 weeks after the last planned dose of treatment)
Time to achieve <LLOQ undetectable HCV RNA(up to 16 weeks)
The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have ≥LLOQ HCV RNA at the end of study drug treatment (EOT)(up to 16 weeks)
The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug(4 weeks after the last planned dose of the study drug)
The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT)(48 weeks either after the last planned dose of study drug or after time of failure)
The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT)(up to 16 weeks)
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)(up to 20 weeks)
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug(24 weeks after the last planned dose of the study drug)
The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure(48 weeks either after the last planned dose of study drug or after time of failure)