R-ITP: Clinical Evaluation of Rituximab in Primary Immune Thrombocytopenia - R-ITP Study

Keio University School of Medicine , Yoshitaka miyakawa0 个研究点目标入组 24 人开始时间: 2011年8月12日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 24

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

We demonstrated the efficacy and safety of rituximab in Japanese patients with chronic ITP. The response rate was similar to that in previous reports in the US and Europe. We plan to propose that the Japanese government approve chronic ITP as a new indication for rituximab.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 ot applicable（—）
性别: All

入选标准

•1)Diagnosis of ITP according to guidelines (The Study Group for Intractable Hematopoietic Diseases supported by the Ministry of Health and Welfare, Japan. 1991) at least 12 months before entry
•2)A platelet count <=30,000/micro L(week -4,-2 before inclusion)
•3)ECOG performance status 0-2
•4)Patients>=20 years old
•5)Patient who was ineffective or intolerable for steroid
•6)Patient who was ineffective or judged as being inappropriate for splenectomy by investigators
•7)Patient who was ineffective or intolerable or judged as being inappropriate by investigators for thrombopoietin-receptor
•8)Hemoglobin>=10g/dL
•9)Creatinine<=2mg/dL
•10)Total bilirubin smaller than 1.5 X upper limit of normal,ALT and AST smaller than 3 X upper limit of normal
•11)Written informed consent

排除标准

•1)Patients with past medical history of allergy to Rituximab
•2)Patients with serious somatic symptom(excluding ITP)
•3)Patients with alcoholism within 1 years
•4)Patients with suspected blood disorder (excluding ITP)
•5)Patients with suspected cyclic thrombocytopenia
•6)HIV, HCV,HBc antibody or HBs antigen positivity
•7)Patients with no active malignancy or history
•8)Patients being treated for TIP at study entry(excluding Patients who have taken steroid,azathioprine,danazol,cyclosporin or mycophenolate mofetil during a certain period of time prior to the study entry.)
•9)Patients who have taken platelet transfusion,immunoglobulin therapy ,splenectomy, steroid,and so on drugs within a certain period of time prior to the study entry.
•10)Patients who have taken antineoplastic within 8 weeks prior to study entry
•11)Patients who have taken antibody drugs
•12)Females who are pregnant or desire childbearing.
•13)Patients judged as being inappropriate for this study by investigators
•14)Patients under other clinical trial

研究者

发起方

Keio University School of Medicine , Yoshitaka miyakawa

相似试验

已完成

2 期

Investigator Initiated Clinical Trial of Rituximab for Thrombotic Thrombocytopenic PurpuraThrombotic Thrombocytopenic Purpura

JPRN-jRCT2091220160Saitama Medical University , Department of General Internal Medicine, Yoshitaka Miyakawa8

进行中（未招募）

1 期

Rituximab as second line treatment for ITP. A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study. - RITP study

EUCTR2005-005918-20-SESykehuset Østfold, Fredrikstad20

进行中（未招募）

1 期

Rituximab as second line treatment for ITP: A Multicentre, Randomized, Double blind,Placebo-controlled, Phase III study. The RITP study” - The RITP study” Protocol version 5

EUCTR2005-005918-20-GBRikshospitalet110

进行中（未招募）

1 期

Rituximab as second line treatment for ITP:A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.The RITP study” - RITP studyImmune thrombocytopenic purpura (ITP)MedDRA version: 9.1Level: LLTClassification code 10021245Term: Idiopathic thrombocytopenic purpura

EUCTR2005-005918-20-FRRikshospitalet110

招募中

不适用

Remission induction with rituximab in Japanese patients with ANCA-associated vascutlitis

JPRN-UMIN000020329The strategic study group to establish evidences for the treatment guidelines of intractable vasculitis50