Chronic Hepatitis C Virus MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: VX-222
Product Code: VX-222
Pharmaceutical Form: Tablet
CAS Number: 1026785-55-6
Current Sponsor code: VX-222
Other descriptive name: VCH-222, BCH-32222, C07062202-G
Concentration unit:
Sponsors
Vertex Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects (male and female, including those of childbearing potential) must be between the ages of 18 and 70 years - Subjects must have genotype 1 CHC and laboratory evidence of HCV infection for at least 6 months before the Screening Visit - Subjects must have documentation of compensated cirrhosis - Subjects must fit one of the following categories: • Treatment-naïve: never received treatment for hepatitis C • Prior null responder: had =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor -History of any illness that, in the opinion of the investigator or general practitioner might confound the results of the study or pose an additional risk to the subject - Any contraindication to Peg-IFN or RBV therapy, or history of severe AEs while on Peg-IFN or RBV - Child-Pugh Score =7, or other clinical evidence of hepatic decompensation - Any other cause of significant liver disease in addition to hepatitis C - Diagnosed or suspected hepatocellular carcinoma - History of organ transplant, with the exception of corneal transplants and skin grafts - A medical condition that requires frequent or prolonged use of systemic corticosteroids or immunosuppressive drugs - History of acute pancreatitis - History or other clinical evidence of chronic pulmonary disease associated with functional impairment - History of other evidence of sever retinopathy or clinically significant ophthalmological disorder - History of illicit substance or alcohol abuse within 1 year before the Screening Visit - Blood donation of approximately 1 pint (500 mL) within 56 days before dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antiviral efficacy of a quadruple drug regimen (VX-222, telaprevir, Peg-IFN and RBV) in subjects with genotype 1 CHC with compensated cirrhosis, who are treatment naive or were nonresponders (partial or null) or relapsers to previous Peg-IFN/RBV therapy.;Secondary Objective: To evaluate the safety and tolerability of the quadruple regimen in subjects with compensated cirrhosis To assess the efficacy of quadruple regimen across interleukin-28B (IL-28B) genotypes To characterize HCV variants in subjects on the quadruple regimen who have treatment failure To characterize the pharmacokinetics (PK) of VX-222 and telaprevir in the quadruple regimen in subjects with compensated cirrhosis;Primary end point(s): The proportion of subjects who have an SVR (i.e., sustain an HCV RNA concentration below the lower limit of quantitation at 12 weeks after last planned dose of treatment (SVR12);Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -The safety and tolerability as assessed by AEs, vital signs, 12-lead electrocardiograms (ECG), and laboratory assessments (serum chemistry, hematology, and urinalysis) - Proportion of subjects who have an SVR24 weeks after the last planned dose of the study drug (SVR24) - Proportion of subjects who achieve undetectable HCV RNA at Weeks 2,4,8, and 12 and <LLOQ at the end of treatment -Proportion of subjects who have on-treatment virologic failure, defined as subjects who either meet a futility rule or complete assigned treatment duration and have detectable HCV RNA at the end of study drug treatment - Proportion of subjects who relapse at end of treatment - The association of IL-28B genotype with SVR12 - The amino acid sequence of the NS3 and NS5B proteins in subjects who have treatment failure - VX-222, telaprevir, RBV plasma concentrations; and Peg-IFN serum concentrations;Timepoint(s) of evaluation of this end point: up to 52 weeks | — |
Countries
Canada, Germany, Poland, United Kingdom, United States
Contacts
Public ContactMedical Information Center
Vertex Pharmaceuticals Incorporated
Outcome results
None listed