NCT05743400

Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation

Thymoglobulin® Pharmacokinetics for Graft-versus Host Disease in Children and Adults Undergoing Hematopoietic Stem Cell Transplantation

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

Thymoglobulin is widely applied as serotherapy in order to prevent acute graft-versus-host disease (GvHD) and graft rejection in patients undergoing non-Human Leukocyte Antigen (HLA)-identical hematopoietic stem cell transplantations (HSCT), with a delicate balance between prevention of GvHD and the promotion of immune reconstitution. Thymoglobulin is known as a drug with high pharmacokinetic (PK) variability. This variability influences drug exposure, which in turn determines the drug response of pharmacodynamics (PD). In order to maintain efficacy while reducing adverse effects of drugs across the entire age range, identification of the PK/PD relationships and the effect of growth and maturation on the different PK and PD parameters involved are crucial. The investigators hypothesise that a better knowledge of Thymoglobulin PK and its covariates would help to individualise dosage regimen and would improve clinical outcomes, such as GvHD and immune reconstitution. The investigators aim to build a population PK model of Thymoglobulin in order to study PK variability and its covariates. This model will help in optimizing dosage regimen in an individually way.

Conditions

• Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy

Interventions

Type	Name	Description
DRUG	Thymoglobulin 25 milligrams (mg) Injection	Patients will receive thymoglobulin between 5 and 20 milligrams/kilograms (mg/kg) as an intravenous infusion over a period of 2 to 5 days depending on the dose and the transplant package chosen by the physician.
BIOLOGICAL	blood test	Thymoglobulin® serum levels Time frame : samples will be drawn at the following points : * 1 after each end of perfusion ; * 1 though concentration before each perfusion ; * 3 blood samples in 3 different days during the first week; * 1 weekly for 2 weeks post HSCT.

Timeline

• Start date: 2023-09-25
• Primary completion: 2025-04-25
• Completion: 2025-04-25
• First posted: 2023-02-24
• Last updated: 2024-09-19

Locations

2 sites across 1 country: France