A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
Part of paid clinical trials in Bentonville, Arkansas.
- Sponsor
- argenx
- Study ID
- NCT04812925
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
- Primary Immune Thrombocytopenia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- efgartigimod PH20 SC — BIOLOGICALSubcutaneous injection with efgartigimod PH20 SC
Study Details
A Phase 3 study to evaluate the safety and efficacy of efgartigimod PH20 subcutaneous in adult patients with primary immune thrombocytopenia
Key Dates
- Start date
- Nov 17, 2021
- Status verified
- Jan 2026
- Primary completion
- Oct 1, 2026
- Completion
- Oct 1, 2026
Study Design
- Enrollment
- 173 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: efgartigimod PH20 SCPatients receiving efgartigimod PH20 SC treatment
Primary Outcome Measure
Incidence, frequency, and severity of adverse events (AEs), AEs of special interest (AESIs), and serious AEs (SAEs) [ Time Frame: 216 weeks ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Investigator Site 0010116 | Bentonville | Arkansas | 72758 | - |
| Investigator site 0010045 | Washington D.C. | District of Columbia | 20007 | - |
| Investigator Site 0010062 | Fort Wayne | Indiana | 46804 | - |
| Investigator site US0010042 | Iowa City | Iowa | 52242 | - |
| Investigator Site 0010095 | Oklahoma City | Oklahoma | 73142 | - |
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