EUCTR2009-010806-12-GB进行中（未招募）1 期
A multi-center, randomized, open label, controlled study to compare the Sustained Virological Response during treatment with Neoral or tacrolimus in maintenance liver transplant recipients treated with pegylated interferon and ribavirin for recurrent Hepatitis C - SUSTAI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •Male or female recipients of first liver transplant aged 18-70 years
- •Liver transplant performed at least 6 months and up to 10 years prior randomization and due to HCV cirrhosis.
- •Immunosuppressive regimen based on tacrolimus (twice- or once-daily formulations) for at least 6 months prior to randomization
- •Diagnosis of HCV genotype 1 or 4 infection confirmed at screening
- •Indication of treatment with Peg-IFN and ribavirin due to histological evidence of chronic HCV infection defined as a fibrosis stage equal or greater than 1 using the Ishak-Knodell scoring system (IK =1) in a liver biopsy performed at screening or up to 4 months prior to randomization
- •Patients must give written informed consent before any study assessment is performed.
- •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
- •Serum creatinine >150 µmol/L (1.7 mg/dL) or eGFR < 50 mL/min (Cockcroft-Gault formula)
- •Multi-organ transplant recipients
- •Recent episode of steroid treated acute rejection (AR) within 3 months prior to randomization, or >1 steroid-treated episode of AR in the last 6 months, or any number of steroid-resistant AR episodes in the last 6 months including evidence of chronic rejection or ductopenia
- •Evidence of conditions that could cause graft dysfunction other than HCV infection
- •Patients with signs of decompensated liver disease, defined as presence of ascites, variceal bleeding, encephalopathy or deteriorated hepatic synthetic function (albumin <3.5g/dL, or direct bilirubin >2 x ULN or, INR >1.5)
- •Co-infection with HIV or Hepatitis B (defined as HBsAg-positive)
- •Use of mTOR inhibitors (everolimus or sirolimus) in the 6 months prior to screening
- •Antiviral treatment for HCV administered at any time after liver transplantation
- •Patients on daily doses of corticosteroids higher than 5 mg/day
- •Patients with fibrosing cholestatic hepatitis
- •Patients with current diagnosis of malignancies, including lymphoproliferative disorders
- •Patients with platelet count <70,000/mm3 or neutrophiles <1,500/mm3
- •History of HCC outside Milan criteria based on radiology or UCSF criteria based on analysis of the explant
- •History of malignancy of any organ system within the past 5 years (other than non-metastatic basal or squamous cell carcinoma of the skin)
- •Concomitant disease such as uncontrolled severe hypertension, heart failure, significant coronary heart disease, uncontrolled diabetes, obstructive pulmonary disease that could limit the participation until the completion of the trial
- •Patients with conditions that could potentially worsen with antiviral treatment, such as severe psychiatric disease, auto-immune diseases and others
- •Patients with clinically significant systemic infection
- •Use of other investigational drugs at the time of enrollment or within 30 days or 5 halflives of enrollment, whichever is longer
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or to antiviral therapy
- •Women of child bearing potential, defined as all women physiologically capable of
- •becoming pregnant including women whose career, lifestyle, or sexual orientation
- •precludes intercourse with a male partner, and women whose partners have been sterilizedby vasectomy or other means, unless they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. Periodic abstinence (e.g., calendar, ovulation, symptom thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •A negative pregnancy test at Visit 1 must be obtained immediately prior to initiation of ther
研究者
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