Phase
Condition
White Cell Disorders
Dysfunctional Uterine Bleeding
Platelet Disorders
Treatment
Efgartigimod IV
Placebo IV
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Is at least 18 years of age and the local legal age of consent for clinical studieswhen 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 (ITP) of more than 12months on the date of informed consent form (ICF) signature.
Has documented prior ITP treatment with at least 1 of the following treatments:corticosteroids, intravenous immunoglobulin (IVIg), anti-D immunoglobulin,thrombopoietin receptor agonist (TPO-RAs), or rituximab.
Has documented insufficient response to a prior ITP treatment (the specific criteriacan be found in the protocol).
Has documented prior response defined as 1 platelet count of ≥50 × 109/L to at least 1 of the following ITP treatments in the 3 years before the date of ICF signature:prednisone, dexamethasone, other or nonspecified corticosteroids, IVIg, or anti-Dimmunoglobulin
Exclusion
Exclusion Criteria:
Other than the indication under study, known autoimmune disease or any medicalcondition that would interfere with an accurate assessment of clinical symptoms ofITP, confound the results of the study or put the participant at undue risk.
Secondary ITP
Nonimmune thrombocytopenia
Autoimmune hemolytic anemia
ITP-associated critical or severe bleeding The complete list of criteria can befound in the protocol.
Study Design
Connect with a study center
Krankenhaus der Elisabethinen Linz GmbH
Linz, 4020
AustriaActive - Recruiting
University Hospital Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, 6003
BulgariaActive - Recruiting
St James's Hospital - Cancer Clinical Trials Office
Dublin, D08 NHY1
IrelandActive - Recruiting
Azienda ULSS 7 Pedemontana
Bassano del Grappa, 36061
ItalyActive - Recruiting
Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
Firenze, 50134
ItalyActive - Recruiting
AO Maggiore Della Carita
Novara, 28100
ItalyActive - Recruiting
U.O.C. Ematologia Ospedale Santa Maria delle Croci
Ravenna, 48121
ItalyActive - Recruiting
AO Ordine Mauriziano di Torino
Torino, 10128
ItalyActive - Recruiting
Azienda Sanitaria Universitaria Integrata
Trieste, 34125
ItalyActive - Recruiting
Pratia Onkologia Katowice
Katowice, 40-519
PolandActive - Recruiting
Complejo Hospitalario Universitario A Coruna
La Coruna, 15006
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainActive - Recruiting
Hospital General Universitario Morales Meseguer
Murcia, 30008
SpainActive - Recruiting
University Hospital Quironsalud Madrid
Pozuelo de Alarcon, 28223
SpainActive - Recruiting
Hospital Clinico Universitario - University of Valencia
Valencia, 46010
SpainActive - Recruiting
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, CV2 2DX
United KingdomActive - Recruiting
Glasgow Royal Infirmary - North Glasgow University Hospital Division
Glasgow, G4 0ET
United KingdomActive - Recruiting
Barts and the London Pathology & Pharmacy Building - Barts Health NHS Trust
London, E1 2ES
United KingdomActive - Recruiting
Hammersmith Hospital, Imperial College School Of Medicine - Imperial College Healthcare NHS Trust
London, W12 0HS
United KingdomActive - Recruiting
Royal Cornwall Hospital (RCH)
Truro, TR1 3LJ
United KingdomActive - Recruiting
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesActive - Recruiting
Regional Cancer Care Associates, LLC (RCCA)
Little Silver, New Jersey 07739
United StatesActive - Recruiting
Clinical Research Alliance Inc.
Westbury, New York 11590
United StatesTerminated
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.