A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Leucemia linfática crónica y otros SLPC, Trasplante de progenitores hematopoyéticos, Trombopenia inmune primaria, Linfoma
CENTRO INVESTIGADOR
H.U. Quirónsalud Madrid
INVESTIGADOR PRINCIPAL
Maria Aranzazu Alonso Alonso
CENTRO INVESTIGADOR
H.U. Ramón y Cajal
INVESTIGADOR PRINCIPAL
Javier Lopez Jimenez
FECHA DE APERTURA
Enero, 2025
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Is at least 18 years of age and the local legal age of consent for clinical studies when 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 12 months 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 (for participants who are nonsplenectomized and Rho(D)- positive), thrombopoietin receptor agonist (TPO-RAs), or rituximab
Has documented insufficient response to a prior ITP treatment with corticosteroids, IVIg, anti-D immunoglobulin (for participants who are nonsplenectomized and Rho(D)-positive), TPO-RAs, rituximab (the specific criteria can be found in the protocol).
Has documented prior response defined as 1 platelet count of 50×10^9/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-D immunoglobulin (for participants who are nonsplenectomized and Rho(D)-positive).
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 12 months 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 (for participants who are nonsplenectomized and Rho(D)- positive), thrombopoietin receptor agonist (TPO-RAs), or rituximab
Has documented insufficient response to a prior ITP treatment with corticosteroids, IVIg, anti-D immunoglobulin (for participants who are nonsplenectomized and Rho(D)-positive), TPO-RAs, rituximab (the specific criteria can be found in the protocol).
Has documented prior response defined as 1 platelet count of 50×10^9/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-D immunoglobulin (for participants who are nonsplenectomized and Rho(D)-positive).
CRITERIOS DE EXCLUSIÓN
Other than the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of ITP, 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
Secondary ITP
Nonimmune thrombocytopenia
Autoimmune hemolytic anemia
ITP-associated critical or severe bleeding
DESCRIPCIÓN
To evaluate the efficacy of efgartigimod IV compared with placebo IV in the extent of disease control
PALABRAS CLAVE
donor lymphocyte infusion, immune thrombocytopenia, leucemia linfocítica crónica (llc / cll)
