A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
Recruiting
Phase 2
Phase 3
Interventional Study
Immune Thrombocytopenia (ITP)
ITP - Immune Thrombocytopenia
ITP
Immune Thrombocytopenic Purpura
Immune Thrombocytopenic Purpura ( ITP )
Idiopathic Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura (ITP)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 17
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- argenx · Industry
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About This Trial
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. At the end of the treatment period (up to 24 we…
Trial Locations
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Eligibility Criteria
Inclusion 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…
Contacts