Chronic hepatitis C infection MedDRA version: 12.1 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV)
Conditions
Interventions
Product Name: Telaprevir
Product Code: VX-950
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: telaprevir
CAS Number: 402957-28-2
Current Sponsor code: VX-950
Other descriptive name: -
Con
Sponsors
Janssen Medical Affairs EMEA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be a man or woman, between 18 and 70 years of age, inclusive 2. Have evidence of HCV infection genotype 1 (molecular assay) 3. Have a quantifiable plasma HCV RNA 4. Have documentation of liver fibrosis assessed by liver biopsy or non-invasive test (eg, fibrotest, fibroscan) showing severe fibrosis (Metavir F3 or Ishak 3-4) or cirrhosis (Metavir F4 or Ishak 5-6). For subjects with Metavir F3 or Ishak 3-4, the liver biopsy or non-invasive test should have been performed within the past 18 months. 5. Have compensated liver disease (Child-Pugh Grade A clinical classification) (see Attachment 1) 6. Have access to the Hepatitis C standard-of-care (Peg-IFN-alfa/RBV) 7. If a women of childbearing potential, must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test documented at the screening visit and a negative serum or urine pregnancy test before the first dose of study drug to ensure that they are not pregnant at the time of starting treatment. 8. If heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives from screening onwards until 4 months (female subject) or 7 months (male subject) after all therapy has ended. Note: Hormonal contraceptives may not be reliable during telaprevir dosing. Therefore, to be eligible for this early access program, subjects should use 2 other effective birth control methods during telaprevir combination therapy and for 2 months after the last intake of telaprevir (see also Section 4.3). 9. Sign the informed consent document indicating that they understand the purpose of and procedures required for the early access program and are willing to participate in the early access program. 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: 1. Is eligible for enrollment into an ongoing clinical study of telaprevir 2. Is infected or co-infected with HCV of another genotype than genotype 1 3. Has a contraindication to the administration of Peg-IFN-alfa or RBV, or medical history or laboratory values that preclude treatment with Peg-IFN-alfa or RBV according to the respective local prescribing information 4. Has a history of having received investigational HCV protease or polymerase inhibitors at any previous time 5. Has signs or symptoms of HCC. Serum alpha-fetoprotein (AFP) level and ultrasonography should be available at screening for all subjects to screen for HCC (both tests should have been done a maximum of 4 months before the screening visit). 6. Has a history of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding esophageal varices, and/or any of the following screening laboratory results: • International Normalized Ratio (INR) of =1.5 • Serum albumin 1.8 times the upper limit of the laboratory normal range, unless isolated or in subjects with Gilbert’s Syndrome. 7. Has a co-infection with active hepatitis B or HIV 8. Has any of the following laboratory abnormalities (assessed at local laboratory) as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS). • Absolute neutrophil count (ANC) 10% of the body, where the palm of one hand equals 1%, or if the hands and feet are affected], rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management) 14. Has clinical evidence of chronic pulmonary disease associated with functional impairment 15. Has a history of uncontrolled severe seizure disorders 16. Has a history or other evidence of a clinically relevant ophthalmologic disorder due to diabetes mellitus or hypertension or history or other evidence of severe retinopathy (eg, cytomegalovirus, macular degeneration) 17. Has a history of major organ transplantation with an existing functional graft with the exception of corneal transplants and skin grafts 18. Is currently enrolled in an investigational drug study or has participated in such a study within 30 days before Day 1 19. Is a woman who is pregnant or breast-feeding 20. Has any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the early access program or prevent the subject from meeting or performing requirements of the early access pro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this early access program are to provide telaprevir for subjects with genotype 1 chronic hepatitis C with severe fibrosis and compensated cirrhosis who reside in countries in which telaprevir is not yet commercially available and who are not eligible for enrollment into an ongoing clinical study of telaprevir, and to collect additional safety and tolerability data on telaprevir treatment in combination with Peg-IFN-alfa and RBV.;Secondary Objective: -;Primary end point(s): In this early access program, all subjects will receive open-label telaprevir in addition to standard of care treatments. Only selected safety and tolerability data will be collected. As such, no formal statistical hypothesis will be tested. | — |
Countries
Austria, Czech Republic, Germany, Greece, Hungary, Italy, Spain
Outcome results
None listed