VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C

Vertex Pharmaceuticals Incorporated64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C Virus

Interventions

VX-222DRUG

400 mg tablets twice daily for oral administration

telaprevirDRUG

1125 mg tablets twice daily for oral administration

ribavirinDRUG

1000 mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (18)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Anaheim, California, United States

Unnamed facility

Riverside, California, United States

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 safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)

Time frame: up to 20 weeks

The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug

Time frame: 24 weeks after the last planned dose of the study drug

The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug

Time frame: 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)

Time frame: 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)

Time frame: up to 16 weeks

Time to achieve <LLOQ undetectable HCV RNA

Time frame: 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)

Data from ClinicalTrials.gov

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