Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation
Recruiting
Phase 4
Interventional Study
Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 35 (estimated)
- Sponsor
- Hospices Civils de Lyon · Other
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About This Trial
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)…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patient receiving Thymoglobulin therapy as part of a first HSCT
* Age ≥ 2 years
* Lansky or karnofsky score ≥ 50%.
* Enrolled in a social security plan
* Patient 18 years of age or older who is informed and has consented to participate in the study or minor patient whose paren…
Contacts