EUCTR2018-001836-24-DE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 follow-up and a long-term extension (CONTRAIL I) - CONTRAIL I
适应症
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: https://unos.org/resources/allocation-calculators/).
- •-Transplantation to occur within defined screening period following
- •informed consent signature.
- •At randomization:
- •-Recipients with no active HCV and HBV replicationIncluded are
- •recipients with HCV antibody positive with no detectable HCV-RNA.
- •Recipients with Hepatitis B infection should have no detectable HBV
- •DNA. 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:
- •-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.
- •-Recipients negative for Epstein Barr virus (EBV) test.
- •-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 who are HCV antibody-positive without documented sustained viral response (SVR) at 12 weeks after finishing anti HCV treatment (e.g., direct-acting antivirals)
- •-Recipients with HCV RNA-positive donors
- •At randomization:
- •-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.?
- •-HCC participants whose explanted liver graft pathology report shows i)
- •pTNM stage beyond T2N0M0, ii) presence of mixed carcinoma, iii)
- •microvascular invasion despite pTNM stage
- •-Participants with body weight < 30 kg or > 180 kg.
研究者
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