Pharmacokinetics of anti-lymphocyte serum in the prevention of GvHD in children and adults receiving allogeneic hematopoietic stem cell transplantation - PHASAL-GA Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501594-39-00

Acronym

69HCL21_1186

Enrollment

Registered

2023-04-13

Start date

2023-07-17

Completion date

2025-11-26

Last updated

2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pediatric and adult patients undergoing HSC allograft procedures with Thymoglobulin® packaging

Brief summary

Measurement of plasma SAL exposure (mean AUC and standard deviation in the study population), calculated using population PK methodology

Detailed description

objective function value (OFV), Coefficient of variation of the AUC

Interventions

DRUGTHYMOGLOBULINE 5 mg/ml

DRUGpoudre pour solution pour perfusion

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Measurement of plasma SAL exposure (mean AUC and standard deviation in the study population), calculated using population PK methodology	—

Secondary

Measure	Time frame
objective function value (OFV), Coefficient of variation of the AUC	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026