JPRN-jRCT2091220160已完成2 期
Investigator Initiated Clinical Trial of Rituximab for Thrombotic Thrombocytopenic Purpura - Rituximab-TTP trial
Saitama Medical University , Department of General Internal Medicine, Yoshitaka Miyakawa0 个研究点目标入组 8 人开始时间: 2014年1月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
The clinical efficacy of rituximab for the treatment of refractory TTP was demonstrated, achieving clinically significant recovery of blood platelet counts and leading to PE cessation. Furthermore, rituximab was well tolerated with no safety concerns observed in this study and therefore is considered a useful therapeutic approach for Japanese TTP patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •Tentative registration
- •1)Definitive or suspected case of acquired TTP according to the Provisional Diagnostic Guideline of TTP of Study Group for Coagulation Disorders (MHLW).
- •-Definitive diagnosis: ADAMTS13 activity <5% and ADAMTS13 inhibitor positive, or presence of all of the 5 clinical symptoms(*) regardless of ADAMTS13 activity.
- •Suspected diagnosis: presence of thrombocytopenia and microangiopathic hemolytic anemia regardless of ADAMTS13 activity. * thrombocytopenia, microangiopathic hemolytic anemia, renal insufficiency, fever, fluctuating levels of neuropsychiatric symptoms.
- •2) 20 to 79 years old at the time of informed consent.
- •3) Written informed consent from the subject or legally acceptable representative
- •Registration
- •1) Patients with refractory or relapsed TTP who fulfill the criteria below.
- •-refractory TTP: fulfill one of the following conditions
- •i) Platelet count <50,000/microL after 5 procedures of plasma exchange.
- •ii) ADAMTS13 inhibitor level of 2 bethesda unit (BU)/mL or more at the time of tentative registration.
- •-relapsed TTP: relapse after at least 30 days from the previous episode.
排除标准
- •Tentative registration
- •1) Secondary TTP associated with drug, hematopoietic stem cell transplantation, solid organ transplantation, collagen disease, malignancy, or pregnancy.
- •2) Congenital TTP (Upshaw-Shulman Syndrome) due to ADMTS 13 deficiency.
- •3) Presence of malignancy.
- •4) Severe hematological, neuropsychiatric, hepatic, pulmonary, endocrinological, immunological, or gastrointestinal conditions not related to TTP.
- •5) Previous exposure to rituximab.
- •6) Male patient who is not able to consent contraception during study period.
- •7) Female patient who is pregnant, lactating, or suspected of pregnancy. Female patient who wish to pregnant during study period.
- •8) Pariticipation in another registration clinical trial and administration of investigational drug during 12 weeks before informed consent.
- •9) Patients inadequate as the subject of the study judged by investigators.
- •Registration
- •1) Known HIV seropositive status.
- •2) Positive status of HBs antigen, HBs antibody, HBc antibody, or HCV antibody except for HBV seropositivity due to vaccination.
研究者
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