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New treatment option for Hematopoietic Stem Cell Transplantation-Associated Thrombotic...
Official title Thymoglobulin® Pharmacokinetics in Patients Undergoing Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT05743400
What this study is testing
What is Thymoglobulin 25 milligrams (mg) Injection?
Thymoglobulin 25 milligrams (mg) Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hematopoietic stem cell transplantation-associated thrombotic microangiopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- 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 parents/guardians have been...
You likely can't join if
- Patient having received serotherapy (Thymoglobulin® or other) within 3 months before this HSCT
- Patient receiving another serotherapy during conditioning (Campath®)
- Patients with uncontrolled acute or chronic infections for which any form of immunosuppression would be contraindicated
- Known hypersensitivity to Thymoglobulin®.
- Pregnant or lactating women
- Patient participating simultaneously in another study of an investigational drug (no exclusion period)
See the full eligibility 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 parents/guardians have been informed and have given consent for the minor patient to participate in...
- Female patients of childbearing potential must have an effective method of contraception (a pregnancy test will also be performed at inclusion).
- Patient having received serotherapy (Thymoglobulin® or other) within 3 months before this HSCT
- Patient receiving another serotherapy during conditioning (Campath®)
- Patients with uncontrolled acute or chronic infections for which any form of immunosuppression would be contraindicated
- Known hypersensitivity to Thymoglobulin®.
- Pregnant or lactating women
- Patient participating simultaneously in another study of an investigational drug (no exclusion period)
- Patient under legal protection or deprived of liberty
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
- Pierre-Bénite, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France; Pierre-Bénite, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.