Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05743400
Status:
RECRUITING
Last Update Posted:
2023-09-29
First Post:
2023-02-15
Brief Title:
Thymoglobulin Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Thymoglobulin Pharmacokinetics for Graft-versus Host Disease in Children and Adults Undergoing Hematopoietic Stem Cell Transplantation
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHASAL-GA
Brief 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 PKPD 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-501594-39-00 | OTHER | EU-CT | None |