Clinical trial • Phase IV • Gastroenterology

HUMAN ALBUMIN SOLUTION for Liver transplantation

Phase IV trial of HUMAN ALBUMIN SOLUTION for Liver transplantation.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Liver transplantation
Trial Stage
Phase IV
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
10-10-2024
First CTIS Authorization Date
16-01-2025

Trial design

Control strategy: restrained albumin administration (when serum concentration is at 20 g/L or below). Intervention strategy: albumin administration to achieve serum concentration above 30 g/L and maintain it >30 g/L for five days. Phase IV trial across 15 sites in France.

Comparator
Control strategy: restrained albumin administration (when serum concentration is at 20 g/L or below). Intervention strategy: albumin administration to achieve serum concentration above 30 g/L and maintain it >30 g/L for five days.
Target Sample Size
400
Trial Duration For Participant
28

Eligibility

Recruits 400 Protected persons (adult legally protected, under judicial protection, guardianship, or supervision) and persons deprived of their liberty are explicitly excluded (NIC4). Participants must be adults (≥18 years) with capacity to understand the purpose and risks and must provide written informed consent (IC1, IC3, IC4). No paediatric population selected; trial record indicates no vulnerable population selected in population settings..

Vulnerable Population
Protected persons (adult legally protected, under judicial protection, guardianship, or supervision) and persons deprived of their liberty are explicitly excluded (NIC4). Participants must be adults (≥18 years) with capacity to understand the purpose and risks and must provide written informed consent (IC1, IC3, IC4). No paediatric population selected; trial record indicates no vulnerable population selected in population settings.

Inclusion criteria

  • {"criterion_text":"- IC1 - Male and female patients equal or above 18 yrs old.\n- IC2 - Recipients of primary liver allografts from a deceased donor (including after cardiac death) and as a single organ (liver only).\n- IC3 - Capability of understanding the purpose and risks of the study.\n- IC4 - Written informed consent"}

Exclusion criteria

  • {"criterion_text":"- NIC1 - Fulminant hepatitis\n- NIC2 - Kidney injury at baseline (eGFR < 50 ml/min in MDRD) including hepatorenal syndrome\n- NIC3 - Use of an induction agent Basiliximab at liver transplantation\n- NIC4 - Protected person (adults legally protected, under judicial protection, guardianship, or supervision), person deprived of their liberty"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Occurrence of Acute Kindey Injury during the first 7 days after liver transplantation (KDIGO criteria)","definition_or_measurement_approach":"Defined and measured using KDIGO criteria; occurrence of AKI during the first 7 days after liver transplantation."}

Secondary endpoints

  • {"endpoint_text":"- Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation (KDIGO Criteria)","definition_or_measurement_approach":"Defined and staged using KDIGO criteria during the first 7 days after transplantation."}
  • {"endpoint_text":"- Hospital length of stay after liver transplantation defined by standardized checklist of discharged criteria","definition_or_measurement_approach":"Measured as days in hospital after transplantation using a standardized checklist of discharge criteria."}
  • {"endpoint_text":"- Postoperative Tacrolimus-induced neurotoxicity at D28","definition_or_measurement_approach":"Assessment of tacrolimus-induced neurotoxicity up to Day 28 post-surgery (evaluated at D28)."}
  • {"endpoint_text":"- Discontinuation of anticalcineurin inhibitor at D28.","definition_or_measurement_approach":"Occurrence of discontinuation of calcineurin inhibitor therapy assessed up to Day 28."}
  • {"endpoint_text":"- Occurrence of postoperative infections at D28","definition_or_measurement_approach":"Occurrence of postoperative infections assessed up to Day 28."}
  • {"endpoint_text":"- Acute graft rejection (biopsy proved) at D28","definition_or_measurement_approach":"Biopsy-proven acute graft rejection assessed up to Day 28."}
  • {"endpoint_text":"- Occurrence of early graft dysfunction (Olthoff criteria)","definition_or_measurement_approach":"Defined and measured using Olthoff criteria for early graft dysfunction."}
  • {"endpoint_text":"- Duration of mechanical ventilation at D28","definition_or_measurement_approach":"Measured duration of mechanical ventilation (hours/days) up to Day 28."}
  • {"endpoint_text":"- Occurrence of reintubation at D28","definition_or_measurement_approach":"Occurrence of reintubation events assessed up to Day 28."}
  • {"endpoint_text":"- Duration of Intensive Care Unit length of stay up to D28","definition_or_measurement_approach":"Measured ICU length of stay (days) up to Day 28."}
  • {"endpoint_text":"- Occurence of Intensive Care Unit readmission after discharge of Intensive Care Unit up to D28","definition_or_measurement_approach":"Occurrence of ICU readmission after initial discharge, assessed up to Day 28."}
  • {"endpoint_text":"- Mortality within the first 28 days following surgery","definition_or_measurement_approach":"All-cause mortality assessed within 28 days post-surgery."}
  • {"endpoint_text":"- Defined as a lymphocyte count less than 1.2× 103 cells/µL","definition_or_measurement_approach":"Lymphopenia defined by absolute lymphocyte count < 1.2 × 10^3 cells/µL."}
  • {"endpoint_text":"- Using flow cytometry","definition_or_measurement_approach":"Measurement approach: flow cytometry (for relevant immunophenotyping endpoints)."}
  • {"endpoint_text":"- Using the Seahorse analyzer measuring mitochondrial respiration","definition_or_measurement_approach":"Measurement approach: Seahorse analyzer to measure mitochondrial respiration parameters."}
  • {"endpoint_text":"- Measured using expression of HLA-DR on peripheral monocytes, plasmatic levels of IL-10, MDSC, RNA seq analysis on peripheral blood mononuclear cell","definition_or_measurement_approach":"Measurement approach: HLA-DR expression on peripheral monocytes, plasma IL-10, MDSC quantification and RNA-seq on PBMCs."}
  • {"endpoint_text":"- Plasmatic levels of IL-6","definition_or_measurement_approach":"Measurement approach: plasma IL-6 concentration measurement."}

Recruitment

Planned Sample Size
400
Recruitment Window Months
43
Consent Approach
Written informed consent required from participants; participants must be adults (≥18) capable of understanding study purpose and risks (IC3, IC4). Subject information and informed consent forms for adults are provided (documents: L_SIS and ICF adults) in French.

Geography

Total Number Of Sites
15
Total Number Of Participants
400

France

Earliest CTIS Part Ii Submission Date
12-12-2024
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
354
Number Of Sites
15
Number Of Participants
400

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Intensive care
Contact Person Name
Antoine DEWITTE
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Digestive surgery
Contact Person Name
Ephrem SALAME
Contact Person Email
e.salame@chu-tours.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hepatology
Contact Person Name
Claire FRANCOZ
Contact Person Email
claire.francoz@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Anaesthesia-Reanimation
Contact Person Name
Gilles LEBUFFE
Contact Person Email
Gilles.LEBUFFE@chu-lille.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Intensive care
Contact Person Name
Emmanuel WEISS
Contact Person Email
emmanuel.weiss@aphp.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Liver diseases
Contact Person Name
Pauline HOUSSEL-DEBRY
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hepatology
Contact Person Name
Jean Baptiste HIRIART
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hepatology
Contact Person Name
Georges Philippe PAGEAUX
Contact Person Email
gp-pageaux@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Hepatology
Contact Person Name
Sebastien DHARANCY
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Intensive care
Contact Person Name
Eric LEVESQUE
Contact Person Email
e.levesque@chu-tours.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Intensive care
Contact Person Name
Clément MONET
Contact Person Email
c-monet@chu-montpellier.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hepatology and intensive care
Contact Person Name
Philippe ICHAI
Contact Person Email
philippe.ichai@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Intensive care
Contact Person Name
Marie-Charlotte DELIGNETTE
Site Name
Hospices Civils De Lyon
Department Name
Anaesthesia-Reanimation
Contact Person Name
Céline GUICHON
Contact Person Email
celin.guichon@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Medical ICU and Infectiology
Contact Person Name
Jean-Marc TADIE
Contact Person Email
jeanmarc.tadie@chu-rennes.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire De Rennes
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
HUMAN ALBUMIN SOLUTION
Active Substance
HUMAN ALBUMIN SOLUTION
Modality
Peptide/protein/enzyme
Routes Of Administration
Solution for infusion (intravenous infusion)
Route
Intravenous (infusion)
Authorisation Status
Authorised (product used under marketing authorisation / SmPC)
Starting Dose
Human Albumin 20% 100ml

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