Status:
RECRUITING
A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
Lead Sponsor:
argenx
Conditions:
Immune Thrombocytopenia (ITP)
ITP - Immune Thrombocytopenia
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07194850
Start Date
October 20 2025
End Date
October 1 2030
Last Update
January 8 2026
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Institutul Clinic Fundeni
Bucharest, Romania, 022328
2
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
3
Hospital Sant Joan de Deu Barcelona
Esplugues de Llobregat, Spain, 08950
4
Hospital Infantil Universitario Nino Jesus (HIUNJS)
Madrid, Spain, 28009