EUCTR2018-001836-24-IT进行中（未招募）1 期
A 12-month, open-label, multicenter, randomized, safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) study of two regimens of anti-CD40 monoclonal antibody, CFZ533 vs. standard of care control, in adult de novo liver transplant recipients with a 12-month additional followup (CONTRAIL I). - CONTRAIL I
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 128
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
- •Screening period up to liver transplantation:
- •- Male or female subjects between 18 to 70 years of age.
- •- Recipients of a primary liver transplant from a deceased donor.
- •- Up to date vaccination as per local immunization schedules.
- •- Recipients tested negative for HIV.
- •- MELD score = 30 (based on laboratory values, using the United Network for Organ Sharing (UNOS) MELD calculator: MELD calculator:
- •https://unos.org/resources/allocation-calculators/).
- •At randomization (Day 8±2):
- •- Recipients with no active HCV and HBV replication. Recipients with HCV
- •antibody positive should have no detectable HCV-RNA. Recipients with
- •Hepatitis B infection should have no detectable HBV DNA by PCR). Cases
- •of spontaneous HCV clearance should be discussed with sponsor.
- •- Allograft is functioning at an acceptable level by the time of randomization as defined by AST, ALT, Total Bilirubin, and Alkaline Phosphatase levels = 5 times ULN.
- •- Renal function (eGFR, MDRD-4 formula) = 30 mL/min/1.73 m2 based on most recent post-transplant value prior to randomization.
- •- Recipients who have been initiated on an immunosuppressive regimen that contains TAC, mycophenolate mofetil (MMF) and corticosteroids (CS) as per protocol.
- •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 103
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Screening period up to liver transplantation:
- •- Use of other investigational drugs at screening within 30 days or 5 half-lives of screening.
- •- Recipients of multiple solid organ or islet cell transplants, or recipients that have previously received a tissue transplant, or a combined liver-kidney transplant.
- •- Recipients of a liver from a donor after cardiac death (DCD), from a living donor, or of a split liver.
- •- Recipient who tests negative for Epstein Barr virus (EBV).
- •- Recipients receiving an ABO incompatible allograft.
- •- History of malignancy of any organ system (except hepatocellular carcinoma (HCC) or localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •- Hepatocellular carcinoma that does not fulfill Milan criteria (1 nodule = 5 cm,2-3 nodules all < 3 cm, without evidence of metastatic disease or vascular invasion) at the time of transplantation.
- •- Recipients transplanted for acute liver failure (does not apply to acute on chronic liver failure).
- •- Any use of antibody induction therapy, or use of any immunosuppressive medications (or other medications prohibited by the protocol)
- •- Patients who have received a live vaccine within four weeks prior to transplantation.
- •- Recipients with donors HIV positive.
- •- Recipients with donors HBsAg positive.
- •- Recipients with positive HCV antibody without proof of sustained viral response (SVR) 12 weeks after anti HCV treatment. Recipients with donors
- •HCV positive.
- •- Recipients with donors with macrovesicular steatosis > 30%.
- •- Pregnant or nursing (lactating) women.
- •At randomization (Day 8±2):
- •- Any post-transplant history of thrombosis, occlusion or stent placement in any hepatic arteries, hepatic veins, portal vein or inferior vena cava at any time during the run-in period prior to randomization.
- •- Recipients with an absolute neutrophil count of < 1,000/mm³ or white blood cell count of < 2,000/mm³.
- •- Recipients with clinically significant systemic infection requiring use of intravenous (IV) antibiotics.
- •- Evidence of active tuberculosis (TB) infection (after anti-TB treatment, patients with history of latent TB may become eligible according to national guidelines).
- •- Recipients who are on renal replacement therapy at randomization.
- •- Any episode of acute rejection or suspected rejection prior to randomization.
研究者
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