JPRN-jRCTs031230310招募中2 期
A pilot study of the long-term safety and efficacy of oral sirolimus in patients with relapsed or refractory acquired chronic pure red cell aplasia - A pilot study of sirolimus for aPRCA
akazawa Hideyuki0 个研究点目标入组 5 人开始时间: 2023年8月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Common criteria of acquired chronic pure red cell aplasia (PRCA): the diagnosis referred to a clinical guide for PRCA by a Japanese National Research Group on Idiopathic Bone Marrow Filure Syndromes of the Ministry of Health, Labour, and Welfare, revised in 2021.
- •(2) Hemoglobin (Hb) level of less than 9 g/dL within 4 weeks before informed consent
- •(3) At least one of the indications listed below (a) to (d):
- •(a) a refractory disease: anemia being refractory to cyclosporine (CsA) treatment with a full dose for preceding >= months
- •(b) an intolerant disease: having CsA treatment being withdrawn due to its adverse events (ex. renal toxicity, hypertension)
- •(c) an intoerant disease: withholding CsA treatment due to its adverse events (ex. renal toxicity, hypertension)
- •(d) a relapsed disease: anemia being relapsing due to dose reduction or cesation of CsA treatment after clinical response to CsA
- •(4) Age 18 years or above
- •(5) Written informed consent
排除标准
- •Exclusion criterias:
- •(1) A woman during pregnancy or breastfeeding, or a man or woman without consent to contraception until 12 weeks after last dose of administration of the study drug
- •(2) Clinical symptoms of interstitial lung disease such as cough, dyspnea, or fever
- •(3) A medical history of sirolimus or other mTOR inhibitors
- •(4) A medical history of immunosuppressive therapy (cyclosporine, corticosteroid, cyclophosphamide, etc.) for acquired chronic pure red cell aplasia within 5 weeks before consent.
- •(5) A major surgery, requiring red blood cell transfusion, such as a surgery of a body cavity or a surgery with 3 or more sutures (including, biopsy), being scheduled between 2 weeks prior to the first dose of the study drug and 1 year after the consent
- •(6) A hematopoietic stem cell transplantation scheduled within 6 months of the consent
- •(7) Any of the laboratory results within 4 weeks of the consent; platelet count < 75,000/mm3, neutrophil count < 1,000/mm3, of white blood cell count < 2,500/mm3
- •(8) AST or ALT > 3 times the upper limit of the reference range within 4 weeks of the consent
- •(9) Child-Pugh C
- •(10) A history of allergic reactions to sirolimus or additives in the test drug
- •(11) Immunodeficiet state such as HIV infection or primary immunodeficiency syndrome
- •(12) Any of the following; a-d
- •a) HBs Ag positive
- •b) HBV-DNA positive WHEN either HBs Ab or HBc Ab positive
- •c) With active hepatits with HCV infection (EXCEPT HCV Ab positive with normal liver enzymes)
- •d) A history of infection or suspected infection of Mycobacterium tuberculosis (QFT/T-SPOT positive)
- •(13) A history of cancer within 2 years of consent
- •(14) A medical history of thymoma treatment
- •(15) Active infections
- •(16) A history of intoxication of illicit drug or alcohol within 5 years, or a history of abuse of illicit drug or alcohol within 1 year before consent
- •(17) A history of participation in other clinical trials or clinical studies within 30 days before the consent AND having taken investigational drugs or having used investigational devices
- •(18) Those deemed to be unsuitable by the primary investigator
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