Phase
Condition
Platelet Disorders
Immune Thrombocytopenia (Itp)
Idiopathic Thrombocytopenic Purpura (Itp)
Treatment
efgartigimod
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Ability to understand the requirements of the trial, to provide written informedconsent (including consent for the use and disclosure of research-related healthinformation), and to comply with the trial protocol procedures (including requiredtrial visits).
Patients enrolled in the ARGX-113-1801 trial who completed the 24-weeks trialperiod.
Women of childbearing potential must have a negative urine pregnancy test atbaseline before trial medication (infusion) can be administered.
Women of childbearing potential should use a highly effective or acceptable methodof contraception during the trial and for 90 days after the last administration ofthe IMP. They must be on a stable regimen, for at least 1 month (as listed in theprotocol)
Ability to understand the requirements of the additional 52-week treatment period ofthe trial, to provide written informed consent (including consent for the use anddisclosure of research-related health information), and to comply with the trialprotocol procedures (including required trial visits).
Patient has completed a 52-week treatment period.
Exclusion
Exclusion criteria:
Introduction or continuation of non-permitted medications during the ARGX-113-1801trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusionproteins or live/live-attenuated vaccines).
Pregnant or lactating women, and those intending to become pregnant during the trialor within 90 days after the last dosing.
Patients with known medical history of hypersensitivity to any of the ingredients ofefgartigimod.
Use of any other investigational drug or participation in any other investigationaltrial.
Study Design
Connect with a study center
Investigator Site 0430002
Vienna,
AustriaSite Not Available
Investigator Site 0430003
Vienna,
AustriaSite Not Available
Investigator Site 0320012
Brasschaat,
BelgiumSite Not Available
Investigator Site 0320011
Brugge,
BelgiumSite Not Available
Investigator Site 0320014
Turnhout,
BelgiumSite Not Available
Investigator Site 0320002
Yvoir,
BelgiumSite Not Available
Investigator Site 3590001
Pleven,
BulgariaSite Not Available
Investigator Site 3590002
Sofia,
BulgariaSite Not Available
Investigator Site 4200001
Brno,
CzechiaSite Not Available
Investigator Site 4200008
Olomouc,
CzechiaSite Not Available
Investigator Site 4200006
Ostrava,
CzechiaSite Not Available
Investigator Site 4200007
Praha,
CzechiaSite Not Available
Investigator Site 0330009
Créteil,
FranceSite Not Available
Investigator Site 0330018
Montpellier,
FranceSite Not Available
Investigator Site 0330008
Pessac,
FranceSite Not Available
Investigator Site 0330016
Périgueux,
FranceSite Not Available
Investigator site 9950007
Tbilisi,
GeorgiaSite Not Available
Investigator site 9950008
Tbilisi,
GeorgiaSite Not Available
Investigator site 9950009
Tbilisi,
GeorgiaSite Not Available
Investigator site 9950011
Tbilisi,
GeorgiaSite Not Available
Investigator site 9950012
Tbilisi,
GeorgiaSite Not Available
Investigator Site 0490010
Düsseldorf,
GermanySite Not Available
Investigator Site 0490008
Essen,
GermanySite Not Available
Investigator Site 0360004
Budapest,
HungarySite Not Available
Investigator Site 0360006
Debrecen,
HungarySite Not Available
Investigator Site 0360015
Győr,
HungarySite Not Available
Investigator Site 7
Nyiregyhaza,
HungarySite Not Available
Investigator Site 0360010
Nyíregyháza,
HungarySite Not Available
Investigator Site 0360014
Szombathely,
HungarySite Not Available
Investigator Site 0390014
Milano,
ItalySite Not Available
Investigator Site 0390020
Monza,
ItalySite Not Available
Investigator Site 0390015
Novara,
ItalySite Not Available
Investigator Site 0390010
Ravenna,
ItalySite Not Available
Investigator Site 0390011
Reggio Calabria,
ItalySite Not Available
Investigator Site 0390018
Reggio Emilia,
ItalySite Not Available
Investigator Site 0390019
Rimini,
ItalySite Not Available
Investigator Site 0390009
Siena,
ItalySite Not Available
Investigator Site 0390016
Trieste,
ItalySite Not Available
Investigator Site 15
Gunma,
JapanSite Not Available
Investigator Site 0810015
Hirakata,
JapanSite Not Available
Investigator Site 0810010
Hiroshima,
JapanSite Not Available
Investigator Site 16
Hokkaido,
JapanSite Not Available
Investigator Site 0810017
Iruma,
JapanSite Not Available
Investigator Site 0810022
Kashiwa,
JapanSite Not Available
Investigator Site 0810018
Maebashi,
JapanSite Not Available
Investigator Site 0810021
Niigata,
JapanSite Not Available
Investigator Site 13
Saitama,
JapanSite Not Available
Investigator Site 0810014
Sapporo,
JapanSite Not Available
Investigator Site 0810016
Shibukawa,
JapanSite Not Available
Investigator Site 0810023
Shimotsuke,
JapanSite Not Available
Investigator Site 14
Tochigi,
JapanSite Not Available
Investigator Site 0310006
Den Haag,
NetherlandsSite Not Available
Investigator Site 0310005
Rotterdam,
NetherlandsSite Not Available
Investigator Site 0480012
Gdańsk,
PolandSite Not Available
Investigator Site 0480013
Katowice,
PolandSite Not Available
Investigator Site 0480014
Lublin,
PolandSite Not Available
Investigator Site 0480026
Nowy Sącz,
PolandSite Not Available
Investigator Site 0480011
Łódź,
PolandSite Not Available
Investigator Site 0070006
Kaluga,
Russian FederationSite Not Available
Investigator Site 0070008
Moscow,
Russian FederationSite Not Available
Investigator Site 0070007
Petrozavodsk,
Russian FederationSite Not Available
Investigator Site 0070013
Rostov-on-Don,
Russian FederationSite Not Available
Investigator Site 0070009
Saint Petersburg,
Russian FederationSite Not Available
Investigator Site 0070015
Syktyvkar,
Russian FederationSite Not Available
Investigator Site 0070012
Tula,
Russian FederationSite Not Available
Investigator Site 0070010
Ufa,
Russian FederationSite Not Available
Investigator Site 0340006
Barcelona,
SpainSite Not Available
Investigator Site 0340007
Barcelona,
SpainSite Not Available
Investigator Site 0340009
Madrid,
SpainSite Not Available
Investigator Site 0340014
Madrid,
SpainSite Not Available
Investigator Site 0340012
Palma De Mallorca,
SpainSite Not Available
Investigator Site 0340015
Pozuelo De Alarcón,
SpainSite Not Available
Investigator Site 0340013
Sevilla,
SpainSite Not Available
Investigator Site 0340004
Valencia,
SpainSite Not Available
Investigator Site 0340011
Valencia,
SpainSite Not Available
Investigator Site 0900003
Ankara,
TurkeySite Not Available
Investigator Site 0900006
Ankara,
TurkeySite Not Available
Investigator Site 0900015
Ankara,
TurkeySite Not Available
Investigator Site 0900016
Edirne,
TurkeySite Not Available
Investigator Site 0900013
Istanbul,
TurkeySite Not Available
Investigator Site 0900010
Mersin,
TurkeySite Not Available
Investigator Site 0900007
Sakarya,
TurkeySite Not Available
Investigator Site 0900009
Samsun,
TurkeySite Not Available
Investigator Site 0900017
Tekirdağ,
TurkeySite Not Available
Investigator Site 0900019
Trabzon,
TurkeySite Not Available
Investigator Site 0900004
İzmir,
TurkeySite Not Available
Investigator Site 3800006
Mykolaiv,
UkraineSite Not Available
Investigator Site 0440008
London,
United KingdomSite Not Available
Investigator Site 0440012
Southampton,
United KingdomSite Not Available
Investigator Site 0010045
Washington, District of Columbia 20007
United StatesSite Not Available
Investigator Site 0010037
Ocala, Florida 34474
United StatesSite Not Available
Investigator Site 0010042
Iowa City, Iowa 52242
United StatesSite Not Available
Investigator Site 0010040
Columbus, Ohio 43210
United StatesSite Not Available
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