Hepatitis C virus (HCV) infection MedDRA version: 8.1 Level: LLT Classification code 10019744 Term: Hepatitis C
Conditions
Sponsors
Vertex Pharmaceuticals Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female subjects, 18-65 years of age, inclusive. - Genotype 1 (confirmed by standard testing), chronic hepatitis C, confirmed by detectable plasma HCV RNA. - Judged to be in good health on the basis of medical history and physical examination (including vital signs and ECG), with any chronic medical conditions under stable medical control. - Both Screening Visit 1 and Screening Visit 2 laboratory values must be within protocl-specified laboratory reference ranges. - Must agree to use 2 methods of contraception that are highly effective, one barrier method (condom or diaphragm with spermicidal jelly) with a second method such as oral contraceptives, hormonal implant, injectable contraceptive, an intrauterine device or surgical sterilization (i.e. vasectomy or female surgical sterilization) during and for 24 weeks after the last dose of study medication (unless the subject is a woman of documented non-child-bearing potential). Female subjects and female partners of male subjects must use the same precautions. Male subjects must not father a child while on study, and for 24 weeks after the last dose of the study medications. - Female subjects must have a negative pregnancy test at all visits (screening and pre-dose Day 1) before the first dose of study drugs. - Willing to refrain from the concomitant use of any medications, substances or foods noted in Section 12.8 of the protocol. - Willing to initiate SOC (Peg-IFN and RBV) off-study at the conclusion of study drug dosing, if subjects have detectable virus or relapse. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Received any approved or investigational drug or drug regimen for the treatment of hepatitis C. - Any medical contraindications to Peg-IFN or RBV therapy. - Decompensated liver disease as shown by screening laboratory results. - Any other cause of significant liver disease in addition to hepatitis C. - Diagnosed or suspected hepatocellular carcinoma. - Histologic evidence of hepatic cirrhosis on any liver biopsy. Most recent liver biopsy must be within 2 years before Study Day 1. - Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months. - Hypersensitivity to tartrazine (yellow dye #5). - Men whose female partners are pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: - To assess the proportion of subjects in each group with undetectable plasma HCV RNA, 24 weeks after the completion of the assigned study drug regimen.;Secondary Objective: Secondary objectives: - To assess the proportion of subjects in each group with undetectable plasma HCV RNA, 12 weeks after the completion of the assigned study drug regimen. - To assess the proportion of subjects who received VX-950 (Groups B, C, and D) with undetectable plasma HCV RNA at the completion of the assigned study drug regimen. - To assess the safety of 12 weeks of dosing of VX-950 and peginterferon alfa-2a (Peg-IFN), with and without ribavirin (RBV). - To examine the nucleotide sequence of the NS3·4A region of hepatitis C virus (HCV) isolated from plasma samples during and after completion of study drug dosing. - To examine the pharmacokinetics of VX-950, Peg-IFN and RBV.;Primary end point(s): Primary end point: - Proportion of subjects in each group with undetectable plasma HCV RNA, 24 weeks after the completion of the assigned study drug regimen. Secondary end points: - Proportion of subjects in each group with undetectable plasma HCV RNA, 12 weeks after the completion of the assigned study drug regimen. - To assess the proportion of subjects who received VX-950 (Groups B, C, and D) with undetectable plasma HCV RNA at the completion of the assigned study drug regimen. - Adverse events and clinical laboratory assessments, including alanine aminotransferase (ALT) and other liver function tests. - Genotypic and phenotypic analyses of the NS3·4A HCV region. - Pharmacokinetic assessments of VX-950, Peg-IFN, and RBV. | — |
Countries
Austria, Germany, United Kingdom
Outcome results
None listed