EUCTR2018-003775-35-IT进行中（未招募）1 期
A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment - na
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject or legally authorized representative voluntarily signs informed consent. For subjects unable to provide consent, a fully recognized medical proxy may be used according to local laws.
- •2. Subject is 18 to 75 years old at the time of screening.
- •3. Subject has been diagnosed with primary or secondary autoimmune aTTP based on the following criteria:
- •a. Thrombocytopenia [drop in platelet count =50% or platelet count < 100,000/µL];
- •¿ No more than 3 subjects per arm may be enrolled with a screening platelet count =50,000/ µL.
- •b. Microangiopathic hemolytic anemia [elevation of lactate dehydrogenase (LDH) >2-fold or by presence or increase of schistocytes in peripheral blood smear].
- •4. Willingness to fully comply with study procedures and requirements, and intention to initiate plasma exchange (PEX). Subjects may be provisionally entered into the trial and undergo randomization pending the results of the ADAMTS-13 activity, anti-ADAMTS-13 antibody, and genetic testing for cTTP.
- •5. If female of childbearing potential, subject presents with a negative pregnancy test and agrees to employ adequate birth control measures for the duration of the study. Sexually active males must use an accepted and effective method of contraception during the treatment and until a minimum of 16 days after the last dose administered.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Subject has been diagnosed with congenital TTP.
- •2. Subject has plasma ADAMTS-13 activity> 10% of normal.
- •3. Subject has been diagnosed with another cause of thrombotic microangiopathy (TMA) including: DIC, disseminated malignancy, malignant hypertension, hematopoietic stem cell transplantation, shiga toxin-related
- •and atypical HUS, drug toxicity (e.g. gemcitabine, mitomycin C, clopidogrel) and pregnancy-related thrombocytopenia syndromes (e.g. HELLP, eclampsia).
- •4. Subject has been exposed to another IP within 30 days prior to enrollment or is scheduled to participate in another clinical study involving IP or investigational device during the course of the study.
- •5. Subject has received caplacizumab within 3 months of study enrollment.
- •6. Subject is human immunodeficiency virus positive (HIV+) with unstable disease or CD4+ count =200 cells/mm3 within 3 months screening.
- •7. Subject has had a previous aTTP event in the past 30 days.
- •8. Subject has another underlying progressive fatal disease and/or life expectancy of less than 3 months.
- •9. Subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.
- •10. Subject suffers from a mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude. However, a fully recognized medical proxy will be permitted to provide consent.
- •11. If female, subject is pregnant or lactating.
- •12. Subject is a family member or employee of the Sponsor or investigator.
- •13. Any contraindication to PEX, methylprednisolone and/or rituximab as per prescribing information.
研究者
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