慢性炎症性脱髄性多発根神経炎（CIDP）の成人患者におけるTAK-881とHYQVIAの比較試験

基本情報

NCT ID

NCT06747351

ステータス

募集中

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

59

治験依頼者名

Takeda

概要

The main aim of this study is to evaluate the pharmacokinetic (PK) comparability between TAK-881 and HYQVIA subcutaneous (SC) administration for maintenance therapy of CIDP. The participants who are already receiving intravenous immunoglobulin G (IGIV), conventional subcutaneous intravenous immunoglobulin G (cIGSC), or HYQVIA will be treated with the same dose equivalent as their prior IG treatment with HYQVIA for 20 weeks followed by TAK-881 for 24 weeks. Participants will need to visit the clinic every 3 or 4 weeks until they enter the extension phase. In the extension phase, home infusions are allowed, and visits will occur between every 12 weeks and 24 weeks.

対象疾患

介入

依頼者（Sponsor）

実施施設 (8)