EUCTR2010-023669-23-DE进行中（未招募）不适用
Multicenter, Open-Label, Early Access Program of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Genotype 1 Chronic Hepatitis C Subjects With Severe Fibrosis and Compensated Cirrhosis -
Janssen Medical Affairs EMEA0 个研究点目标入组 3,000 人开始时间: 2011年2月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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 <3.3 g/dL
- •Serum total bilirubin >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) <1,500 cells/mm3
- •Platelet count <90,000 cells/mm3
- •Hemoglobin concentration <12 g/dL in females or <13 g/dL in males
- •Calculated creatinine clearance <50 mL/min
- •potassium <3.5 mmol/L
- •9. Has inadequately controlled thyroid function (TSH)
- •10. Has baseline increased risk for anemia (eg, thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or for whom anemia would be medically problematic
- •11. Has congenital QT prolongation or family history of congenital QT prolongation or sudden death
- •12. Has a history of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease
- •13. Has a history of immunologically mediated disease (eg, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis [defined as affecting >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
研究者
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