Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation
Status:
Not yet recruiting
Trial end date:
2025-02-08
Target enrollment:
Participant gender:
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.