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New treatment option for Immune Thrombocytopenia (ITP)
Official title A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
ClinicalTrials.gov ID: NCT07194850
What this study is testing
What is Efgartigimod IV?
Efgartigimod IV is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for immune thrombocytopenia (itp).
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
- The main purpose of this study is to confirm the correct dose of efgartigimod IV for treating patients aged 12 to younger than 18 years with chronic immune thrombocytopenia (ITP). The study consists of a double-blinded treatment period (DBTP) in which the participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV.
- Phase 3: a large, late-stage study
- Time commitment: about 138 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- Is aged 12 to less than 18 years when completing the informed consent process
- Has a documented duration of primary ITP of more than 12 months on the date the informed consent process is complete
- Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, IVIg, anti-D immunoglobulin, thrombopoietin receptor...
- Has documented prior response, defined as 1 platelet count of ≥50 × 10\^9/L to at least 1 of the following ITP treatments: prednisone, other or...
- Has documented insufficient response to a prior ITP treatment with corticosteroids, IVIg, anti-D immunoglobulin, TPO-RAs, rituximab, or splenectomy
You likely can't join if
- Secondary ITP according to the following definition by the International Working Group (IWG): all forms of immune-mediated thrombocytopenia except...
- Nonimmune thrombocytopenia
- ITP-associated critical or severe bleeding
- History of hereditary thrombocytopenia
See the full eligibility criteria
- Is aged 12 to less than 18 years when completing the informed consent process
- Has a documented duration of primary ITP of more than 12 months on the date the informed consent process is complete
- Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, IVIg, anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab.
- Has documented prior response, defined as 1 platelet count of ≥50 × 10\^9/L to at least 1 of the following ITP treatments: prednisone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin
- Has documented insufficient response to a prior ITP treatment with corticosteroids, IVIg, anti-D immunoglobulin, TPO-RAs, rituximab, or splenectomy
- Has documented mean platelet count of less than 30 x10\^9/L
- Secondary ITP according to the following definition by the International Working Group (IWG): all forms of immune-mediated thrombocytopenia except primary ITP
- Nonimmune thrombocytopenia
- ITP-associated critical or severe bleeding
- History of hereditary thrombocytopenia
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Berlin, Germany
- Genoa, Italy
- Monza, Italy
- Roma, Italy
- Torino, Italy
- Vilnius, Lithuania
- Lodz, Poland
- Lublin, Poland
- Bucharest, Romania
- Belgrade, Serbia
- Kragujevac, Serbia
- Barcelona, Spain
- Esplugues de Llobregat, Spain
- Madrid, Spain
- Cardiff, United Kingdom
- Glasgow, United Kingdom
- Manchester, United Kingdom
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 study runs about 138 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Berlin, Germany; Genoa, Italy; Monza, Italy; Roma, Italy; Torino, Italy and 12 more location(s). 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.