A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
argenx
Study ID
NCT04225156
Phase
PHASE3
Status
Completed

Conditions

  • Primary Immune Thrombocytopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • efgartigimod — BIOLOGICAL
    Intravenous infusion of efgartigimod

Study Details

This is an open-label long-term multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in adult patients with primary ITP.

Key Dates

Start date
Jun 2, 2020
Status verified
Mar 2026
Primary completion
Mar 11, 2026
Completion
Mar 11, 2026

Study Design

Enrollment
101 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: efgartigimod
    patients receiving efgartigimod

Primary Outcome Measure

Frequency and severity of Adverse Events [ Time Frame: Up to 60 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
Investigator Site 0010045Washington D.C.District of Columbia20007-
Investigator Site 0010037OcalaFlorida34474-
Investigator Site 0010042Iowa CityIowa52242-
Investigator Site 0010040ColumbusOhio43210-

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Investigator· Washington D.C., DCInvestigator· Ocala, FLInvestigator· Iowa City, IAInvestigator· Columbus, OH

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