JPRN-jRCT2071210027已完成2 期
Phase 2 clinical trial evaluating the efficacy and safety of ART-001 in patients with slow-flow vascular malformations
agabukuro Hiroshi0 个研究点目标入组 34 人开始时间: 2021年5月25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
- 34
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
- >= 2age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) All sexes, 2 years old and older
- •2) Patients with a diagonisis of venous malformation, lymphatic malformation (lymphangioma) or Klippel-Trenone syndrome.
- •3) Patients must have symptoms caused by slow-flow vascular malformation (i.e. pain, inflammation such as repeated cellulitis, bleeding, disfigurement, etc.)
- •4) Patients who have a intractable slow-flow vascular malformation (i.e. poor response or recurrence for standard treatment, multiple lesions, inoperable, thrombotic, etc.)
- •5) Patients with at least one lesions whose volume is measurableby MRI
- •6) Written consent to participate in this clinical trial has been given by the patient, or by the parent or a legal guardian (for pediatric patients).
排除标准
- •1) Patients with diabetes (type I or type II) or diseases that cause abnormal glucose metabolism
- •2) Patients with renal dysfunction
- •3) Patients with liver dysfunction
- •4) Patients with poorly controlled ischemic heart disease, arrhythmia, or heart failure (NYHA III or IV degree)
- •5) Patients taking drugs that have CYP3A4 inhibitory or inducing effects
- •6) Patients with gastrointestinal disorders that affect drug absorption
- •7) Patients who cannot take the drug orally
- •8) Patients with orthodontic appliances, cochlear implants, etc. that may affect MRI image evaluation
- •9) Patients with inflammatory infections requiring treatment for target lesions within 4 weeks at time of informed consent
- •10) Patients who received invasive treatment including sclerotherapy or laser therapy for target lesions within 12 weeks at time of informed consent
- •11) Patients who have used other PI3Kalpha inhibitors or sirolimus within 12 weeks at time of informed consent.
- •12) Patients who participated in other clinical trials (excluding observational studies) within 12 weeks at time of informed consent
- •13) Patients who disagree with contraception
- •14) Pregnant or lactating female patients
- •15) Patients who are positive for immunological tests (HBs antigen, HCV antibody, HIV antibody, syphilis serum test) by screening test
- •16) Patients who are judged by the investigator to be not eligible for the clinical trial
研究者
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