A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
Recruiting
Phase 3
Interventional Study
Primary Immune Thrombocytopenia (ITP)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 69 (estimated)
- Sponsor
- argenx · Industry
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About This Trial
The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP). After an up to 2 weeks screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV, respectively during the double-blinded treatment period (DBTP). At the end of the treatment perio…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Is at least 18 years of age and the local legal age of consent for clinical studies when signing the informed consent form (ICF).
* Has documented baseline mean platelet count of \<30 x 10\^9/L before randomization
* Has a documented duration of primary immune thrombocytopenia…
Contacts