Study of the safety and efficacy of the drug CFZ533 (Iscalimab) in subjects who have received a liver transplant

Phase 1

• Conditions: iver transplantation; MedDRA version: 20.0 Level: PT Classification code 10024715 Term: Liver transplant rejection System Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-001836-24-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-10
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 128

Inclusion Criteria

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.
At randomization:
-Recipients with no active HCV and HBV replication (no detectable RNA/DNAby PCR).
-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

Exclusion Criteria

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.
-A negative 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) 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 positive for HIV, HBsAg and HCV.
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.?

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified