Clinical trial · Interventional
Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants
Pharmacokinetics and Pharmacodynamics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplant Recipients
NCT01135537CI-TRIAL-00041416terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was closed before 2017 due to inconclusive results from Lab
Summary
Brief summary (as posted)
This study will describe the pharmacokinetic disposition of biologically active rabbit anti-thymocyte globulin (rATG) after a consistent dose of 7.5 mg/kg/course given as part of the conditioning regimen in children undergoing hematopoeitic stem cell transplantation (HSCT).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genetic Disorder | — | UNRESOLVED | — |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
| Metabolic Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thymoglobulin (rATG) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Thymoglobulin
- description
- Thymoglobulin 7.5 mg/kg/course prior to HSCT
- interventionNames
- Biological: Thymoglobulin (rATG)
Primary outcomes (1)
- measure
- Pharmacokinetic Disposition of ATG After a 7.5 mg/kg/Course
- timeFrame
- 100 days
- description
- ATG pharmacokinetic parameters were estimated using a noncompartmental model. Maximum Observed Concentration (Cmax) of ATG After a 7.5 mg/kg/Course was measured
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * All patients who are scheduled to receive ATG 2.5mg/kg/day for 3 days as part of the preparative regimen for HSCT, as determined by the responsible HSCT physician. * Written, informed consent Exclusion Criteria: * Hypersensitivity to rabbit proteins or to any product excipients * Active acute or chronic infections, which would contraindicate any additional immunosuppression * Known pregnancy or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.