Subcategory
Other indications (e.g. myeloproliferative diseases)
Trial Type
other systemic therapies
Description for experts
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
Description for laymen
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
JSON Data
{
"short_title": "ARGX-113-2402",
"data_mode": "910",
"data_mode_number": "000000063",
"official_title": null,
"accrual_state": "running",
"therapeutic_value": "not_applicable",
"therapieansatz_value": "not_applicable",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "not_applicable",
"ctgov_number": null,
"eudract_number": "2024-515451-38",
"general_contact_email": "sal-aml-register@ukdd.de",
"general_contact_phone": "+49 351-45818380",
"hauptpruefer_dd_name": null,
"description_laie_de": " 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\r\n235 / 5.000\r\nEine multizentrische, randomisierte, doppelblinde, placebokontrollierte Parallelarmstudie der Phase 3 mit anschlie\u00dfendem Open-Label-Arm zur Bewertung der Wirksamkeit und Sicherheit von Efgartigimod IV bei erwachsenen Teilnehmern mit prim\u00e4rer Immunthrombozytopenie",
"description_laie_en": " 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",
"description_expert_de": " 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\r\n235 / 5.000\r\nEine multizentrische, randomisierte, doppelblinde, placebokontrollierte Parallelarmstudie der Phase 3 mit anschlie\u00dfendem Open-Label-Arm zur Bewertung der Wirksamkeit und Sicherheit von Efgartigimod IV bei erwachsenen Teilnehmern mit prim\u00e4rer Immunthrombozytopenie",
"description_expert_en": " 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",
"rechtsgrundlage_value": null,
"phase_amg_value": null,
"main_cat_id": 4,
"sub_cat_id": 22
}
