Study of the safety and efficacy of the drug CFZ533 (Iscalimab) in subjects who have received a liver transplant
- Conditions
- iver transplantationMedDRA version: 20.0Level: PTClassification code 10024715Term: Liver transplant rejectionSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2018-001836-24-NL
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 128
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 replication Included 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
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 who have tested positive for HIV.
-Recipients negative for Epstein Barr virus 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method