Hepatitis C virus (HCV) infection MedDRA version: 9.1 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 to 70 years of age, inclusive. - Genotype 1 (confirmed by standard testing), chronic hepatitis C. Chronic (non-acute) disease status must be confirmed by detectable plasma HCV RNA. - Liver biopsy within 3 years of the date of the Screening Visit. - 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 protocol specified laboratory reference ranges. - Did not achieve SVR with at least 1 adequate prior course of Peg-IFN in combination with RBV (Peg-IFN/RBV) as defined by the protocol. Subjects must have received the last dose of Peg-IFN or RBV at least 12 weeks before the screening visit for this study. - Must agree to use 2 methods of contraception that are highly effective, including one barrier method, during and for 24 weeks after the last dose of study drug (unless the subject is a woman of documented non-child-bearing potential). Female partners of male subjects must use the same precautions. - Female subjects of child-bearing potential must have a negative pregnancy test at all visits (screening and predose 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 21. - Able to read and understand the Informed Consent Form (ICF) and willing to sign the ICF and abide by the study restrictions. - Agree not to participate in other clinical studies for the duration of his/her participation in this trial through antiviral follow-up. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any medical contraindications to Peg-IFN or RBV therapy. - Prior response to therapy and failure to achieve SVR which may have been due to treatment non-compliance, in the assessment of the investigator based upon subject’s medical history. - Participation in any clinical trial of a HCV protease inhibitor of any duration. - Participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study). - History of or current evidence of decompensated liver disease defined as a prior or current history of ascites, hepatic encephalopathy, bleeding esophageal or gastric varices. - Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson’s disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. - Diagnosed or suspected hepatocellular carcinoma. - Alcohol or drug abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months. - Women who are pregnant or breast-feeding. - Male partners of women who are pregnant or breast-feeding. - Hypersensitivity to tartrazine (yellow dye #5).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare to control (Group A) (peginterferon alfa-2a [Peg IFN-a-2a] and ribavirin [RBV] for 48 weeks) the proportion of subjects who achieve sustained viral response (SVR, undetectable HCV RNA 24 weeks after completion of treatment) when given telaprevir in combination with: Peg IFN-a-2a and RBV for 24 weeks followed by 24 weeks of Peg IFN a-2a and RBV given alone (Group B); Peg IFN-a-2a for 24 weeks (Group C); Peg IFN-a-2a and RBV for 12 weeks followed by 12 weeks of Peg IFN-a-2a and RBV given alone (Group D).;Secondary Objective: - To compare the proportion of subjects with an end-of-treatment response (ETR) (undetectable HCV RNA at end of treatment) in Groups B, C, and D with the control (Group A). - To compare the proportion of subjects with a continued SVR (undetectable HCV RNA 48 weeks after the end of treatment) in Groups B, C, and D with the proportion of subjects with SVR in the control (Group A). - To assess the safety and tolerability of treatment with telaprevir and Peg-IFN with or without RBV. - To evaluate the nucleotide sequence of the NS3•4A region of HCV isolated from plasma samples during and after completion of study drug dosing. - To evaluate the pharmacokinetics of telaprevir, Peg-IFN-a-2a, and RBV.;Primary end point(s): Primary end point: - Undetectable HCV RNA 24 weeks after the completion of treatment Secondary end points: - Undetectable HCV RNA at end of treatment. - Undetectable HCV RNA 48 weeks after completion of treatment (Groups B, C, and D). - Adverse events and clinical laboratory assessments, including ALT and other liver function tests. - Genotypic and phenotypic analyses of the NS3•4A HCV region. - Pharmacokinetic assessments of telaprevir, Peg-IFN-a-2a, and RBV. | — |
Countries
Germany, Netherlands
Outcome results
None listed