SAA患者におけるウサギ由来ATGの異なる投与量を比較する無作為化試験

基本情報

NCT ID

NCT01844635

ステータス

不明

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

320

治験依頼者名

Nagoya University

概要

The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)