原発性免疫不全症（PID）を有する日本人被験者における免疫グロブリン皮下注射液（ヒト）20％溶液（IGSC、20％）の有効性に関する研究

基本情報

NCT ID

NCT04346108

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

17

治験依頼者名

Takeda

概要

In this study, Japanese participants with primary immunodeficiency diseases were treated with Immune Globulin Subcutaneous (Human), 20% solution, (IGSC, 20%). This study will be in 3 parts: Part 1: Infusions with Immunoglobulin Intravenous (IGIV) every 3 or 4 weeks for 13 weeks. Part 2: Participants will switch to weekly subcutaneous infusions with IGSC, 20% for 24 weeks. Part 3: A subset will receive biweekly subcutaneous infusions with IGSC, 20% for 12 weeks. The main aim of the study is to assess base levels of Immunoglobulin globulin G (IgG) levels in the blood of the participants after weekly and biweekly treatment with IGSC, 20% (in Parts 2 and 3 of the study). Their PID will be treated by their doctor according to their doctor's usual clinical practice.

対象疾患

介入

依頼者（Sponsor）

実施施設 (8)