EUCTR2011-004724-35-DE进行中（未招募）不适用
Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
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. 18 to 70 years old.
- •2. First time liver transplant recipient
- •3. One of the following based on clinical history or by documented HCV RNA and treatment history:
- •a) Treatment-naïve subject
- •- Relapser:
- •- Partial responder: ;
- •- Null responder:.
- •4. > 6 months to 10 years post-liver transplant.
- •5. Subject must be on a stable TAC or CsA containing immunosuppressive regimen, combination with MMF is allowed
- •6. Subject must agree to have a liver graft biopsy: >1 year of liver transplantation within 6 months prior to screening, 6-12 months of transplantation within 3 months,
- •7. The last pre-treatment liver graft biopsy report must reveal fibrosis stage (Metavir) F0-F3.
- •8. Subject is judged to be in moderately good health
- •9. If heterosexually active, a female subject of childbearing potential and a non- vasectomized male subject who has a female partner of childbearing potential must agree to the use of 2 effective methods of contraception from screening onwards until 6 months (female subject) or 7 months (male subject) after the last dose of RBV. Male subjects must also agree not to donate sperm during the study and for 7 months after the last intake of RBV.
- •10. Subject or female partner is not pregnant, planning to become pregnant, or breastfeeding.
- •11. Subject is willing and able to refrain from the concomitant use of medications as described in the section Disallowed Medication”
- •12. Subject is able to read and understand, and is willing to sign the Informed Consent Form (ICF) voluntarily.
- •13. Subject should agree not to participate in other clinical studies for the duration of his/her participation in this study, except for non-interventional or observational studies.
- •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 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Subject is infected or co-infected with non-genotype 1 HCV.
- •2. Subject received treatment with a direct acting antiviral for hepatitis C.
- •3. Subject received HCV treatment following liver transplantation.
- •4. Subject has histological evidence of rejection on the most recent liver graft biopsy
- •5. Subject has a contraindication to the administration of Peg-IFN-alfa or RBV,
- •6. Subject has a pre-existing psychiatric condition that could interfere with the subject’s participation in and completion of the study,:
- •7. Following transplantation, subject has history of decompensated liver disease:
- •8. Subject’s liver graft biopsy used to meet study eligibility criteria and/or clinical condition shows evidence of liver disease in addition to hepatitis C,
- •9. Subject has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma (HCC) cured by liver transplant).
- •10. Family history of congenital QT prolongation or sudden death. History of congenital QT prolongation, drug-induced QT prolongation or Torsade de Pointes, nonsustained or sustained ventricular tachycardia, or baseline QTcF >450 msec.
- •11. Subject has history of seizure disorders unrelated to calcineurin toxicity.
- •12. Uncontrolled diabetes or hypertension post transplantwithin 3 months prior to the screening visit.
- •13. Subject has history or other evidence of clinically significant retinopathy or ophthalmological disorder,
- •14. Subject has history or other clinical evidence of chronic pulmonary disease
- •15. Subject has active hemophilia or other bleeding disorder.
- •16. Subject has evidence of serious or severe bacterial or fungal infection(s), including active tuberculosis.
- •17. Subject has HIV or HBV co-infection.
- •18. Subject has a history of acute or chronic pancreatitis post transplant with exception of gallstone or post ERCP pancreatitis.
- •19. Knowledge of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, current or within 2 years prior to the screening visit that in the investigator’s opinion would compromise the subject’s safety and/or compliance with study procedures.
- •20. Subject has a confirmed Grade 4 laboratory abnormality as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table”) or any other clinically relevant abnormalities in the opinion of the investigator. Subjects with Grade 4 elevations of gamma- glutamyltransferase (GGT) will be allowed to enter the study if there are no other clinically relevant laboratory abnormalities as judged by the investigator.
- •The screening laboratory values of the following variables should meet the acceptable values defined below:
- •- absolute neutrophil count (ANC) = 1,000/mm3;
- •- platelet count = 75,000/mm3;
- •- hemoglobin = 11g/dL;
- •- estimated creatinine clearance (Cockroft-Gault) > 60 mL/min at screening;
- •- potassium and magnesium within normal range;
- •- Grade = 1 uric acid;
- •- Thyroxin stimulating hormone (TSH) and free thyroxine (T4) within normal range, or hyperthyroid and adequately controlled with thyroid treatment, or TSH or free T4 abnormal but considered to be clinically insignificant as judged by the investigator.
研究者
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