A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
NCT ID: NCT04225156
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
101 participants
INTERVENTIONAL
2020-06-02
2026-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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efgartigimod
patients receiving efgartigimod
efgartigimod
Intravenous infusion of efgartigimod
Interventions
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efgartigimod
Intravenous infusion of efgartigimod
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients enrolled in the ARGX-113-1801 trial who completed the 24-weeks trial period.
3. Women of childbearing potential must have a negative urine pregnancy test at baseline before trial medication (infusion) can be administered.
4. Women of childbearing potential should use a highly effective or acceptable method of contraception during the trial and for 90 days after the last administration of the IMP. They must be on a stable regimen, for at least 1 month (as listed in the protocol)
6\. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).
7\. Patient has completed a 52-week treatment period.
Exclusion Criteria
2. Pregnant or lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing.
3. Patients with known medical history of hypersensitivity to any of the ingredients of efgartigimod.
4. Use of any other investigational drug or participation in any other investigational trial.
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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Investigator Site 0010045
Washington D.C., District of Columbia, United States
Investigator Site 0010037
Ocala, Florida, United States
Investigator Site 0010042
Iowa City, Iowa, United States
Investigator Site 0010040
Columbus, Ohio, United States
Investigator Site 0430002
Vienna, , Austria
Investigator Site 0430003
Vienna, , Austria
Investigator Site 0320012
Brasschaat, , Belgium
Investigator Site 0320011
Bruges, , Belgium
Investigator Site 0320014
Turnhout, , Belgium
Investigator Site 0320002
Yvoir, , Belgium
Investigator Site 3590001
Pleven, , Bulgaria
Investigator Site 3590002
Sofia, , Bulgaria
Investigator Site 4200001
Brno, , Czechia
Investigator Site 4200008
Olomouc, , Czechia
Investigator Site 4200006
Ostrava, , Czechia
Investigator Site 4200007
Prague, , Czechia
Investigator Site 0330009
Créteil, , France
Investigator Site 0330018
Montpellier, , France
Investigator Site 0330008
Pessac, , France
Investigator Site 0330016
Périgueux, , France
Investigator site 9950007
Tbilisi, , Georgia
Investigator site 9950008
Tbilisi, , Georgia
Investigator site 9950009
Tbilisi, , Georgia
Investigator site 9950011
Tbilisi, , Georgia
Investigator site 9950012
Tbilisi, , Georgia
Investigator Site 0490010
Düsseldorf, , Germany
Investigator Site 0490008
Essen, , Germany
Investigator Site 0360004
Budapest, , Hungary
Investigator Site 0360006
Debrecen, , Hungary
Investigator Site 0360015
Győr, , Hungary
Investigator Site 0360010
Nyíregyháza, , Hungary
Investigator Site 0360014
Szombathely, , Hungary
Investigator Site 0390014
Milan, , Italy
Investigator Site 0390020
Monza, , Italy
Investigator Site 0390015
Novara, , Italy
Investigator Site 0390010
Ravenna, , Italy
Investigator Site 0390011
Reggio Calabria, , Italy
Investigator Site 0390018
Reggio Emilia, , Italy
Investigator Site 0390019
Rimini, , Italy
Investigator Site 0390009
Siena, , Italy
Investigator Site 0390016
Trieste, , Italy
Investigator Site 0810015
Hirakata, , Japan
Investigator Site 0810010
Hiroshima, , Japan
Investigator Site 0810017
Iruma, , Japan
Investigator Site 0810022
Kashiwa, , Japan
Investigator Site 0810018
Maebashi, , Japan
Investigator Site 0810021
Niigata, , Japan
Investigator Site 0810014
Sapporo, , Japan
Investigator Site 0810016
Shibukawa, , Japan
Investigator Site 0810023
Shimotsuke, , Japan
Investigator Site 0310005
Rotterdam, , Netherlands
Investigator Site 0310006
The Hague, , Netherlands
Investigator Site 0480012
Gdansk, , Poland
Investigator Site 0480013
Katowice, , Poland
Investigator Site 0480011
Lodz, , Poland
Investigator Site 0480014
Lublin, , Poland
Investigator Site 0480026
Nowy Sącz, , Poland
Investigator Site 0070006
Kaluga, , Russia
Investigator Site 0070008
Moscow, , Russia
Investigator Site 0070007
Petrozavodsk, , Russia
Investigator Site 0070013
Rostov-on-Don, , Russia
Investigator Site 0070015
Syktyvkar, , Russia
Investigator Site 0070012
Tula, , Russia
Investigator Site 0070010
Ufa, , Russia
Investigator Site 0340006
Barcelona, , Spain
Investigator Site 0340007
Barcelona, , Spain
Investigator Site 0340009
Madrid, , Spain
Investigator Site 0340014
Madrid, , Spain
Investigator Site 0340012
Palma de Mallorca, , Spain
Investigator Site 0340015
Pozuelo de Alarcón, , Spain
Investigator Site 0340013
Seville, , Spain
Investigator Site 0340004
Valencia, , Spain
Investigator Site 0340011
Valencia, , Spain
Investigator Site 0900003
Ankara, , Turkey (Türkiye)
Investigator Site 0900006
Ankara, , Turkey (Türkiye)
Investigator Site 0900015
Ankara, , Turkey (Türkiye)
Investigator Site 0900016
Edirne, , Turkey (Türkiye)
Investigator Site 0900013
Istanbul, , Turkey (Türkiye)
Investigator Site 0900004
Izmir, , Turkey (Türkiye)
Investigator Site 0900010
Mersin, , Turkey (Türkiye)
Investigator Site 0900007
Sakarya, , Turkey (Türkiye)
Investigator Site 0900009
Samsun, , Turkey (Türkiye)
Investigator Site 0900017
Tekirdağ, , Turkey (Türkiye)
Investigator Site 0900019
Trabzon, , Turkey (Türkiye)
Investigator Site 3800006
Mykolaiv, , Ukraine
Investigator Site 0440008
London, , United Kingdom
Investigator Site 0440012
Southampton, , United Kingdom
Countries
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Other Identifiers
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2019-002101-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ARGX-113-1803
Identifier Type: -
Identifier Source: org_study_id
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