Subcategory
Other indications (e.g. myeloproliferative diseases)
Trial Type
First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts
This is a multicenter, randomized, double-blinded Phase 3 study to assess the efficacy and safety of two different doses of ianalumab (3 and 9 mg/kg) compared to placebo in adult participants with primary ITP.
Description for laymen
This is a multicenter, randomized, double-blinded Phase 3 study to assess the efficacy and safety of two different doses of ianalumab (3 and 9 mg/kg) compared to placebo in adult participants with primary ITP.
JSON Data
{
"short_title": "VAYHIT1",
"data_mode": "910",
"data_mode_number": "000000035",
"official_title": null,
"accrual_state": "running",
"therapeutic_value": "not_applicable",
"therapieansatz_value": "not_applicable",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "first",
"ctgov_number": null,
"eudract_number": "2022-001672-34",
"general_contact_email": "sal-aml-register@ukdd.de",
"general_contact_phone": "+49 351-45818380",
"hauptpruefer_dd_name": null,
"description_laie_de": "Dies ist eine multizentrische, randomisierte, doppelblinde Phase-3-Studie zur Bewertung der Wirksamkeit und Sicherheit von zwei verschiedenen Dosierungen von Analumab (3 und 9 mg/kg) im Vergleich zu Placebo bei erwachsenen Teilnehmern mit prim\u00e4rer ITP.",
"description_laie_en": "This is a multicenter, randomized, double-blinded Phase 3 study to assess the efficacy and safety of two different doses of ianalumab (3 and 9 mg/kg) compared to placebo in adult participants with primary ITP.",
"description_expert_de": "Dies ist eine multizentrische, randomisierte, doppelblinde Phase-3-Studie zur Bewertung der Wirksamkeit und Sicherheit von zwei verschiedenen Dosierungen von Analumab (3 und 9 mg/kg) im Vergleich zu Placebo bei erwachsenen Teilnehmern mit prim\u00e4rer ITP.",
"description_expert_en": "This is a multicenter, randomized, double-blinded Phase 3 study to assess the efficacy and safety of two different doses of ianalumab (3 and 9 mg/kg) compared to placebo in adult participants with primary ITP.",
"rechtsgrundlage_value": null,
"phase_amg_value": null,
"main_cat_id": 4,
"sub_cat_id": 22
}
