JPRN-jRCTs031200055进行中（未招募）3 期
A Singlecenter, single-arm, prospective study assessing efficacy and safety of Sirolimus granules twice daily administration in patients with intractuable vascular malformations - Sirolimus granules twice daily administration for intractuable vascular malformations
Mochizuki Shinji0 个研究点目标入组 11 人开始时间: 2020年6月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 11
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
- >= 1month old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) one month and older
- •2) Patients with intractable vascular anomaly diagnosed by the investigator/subinvestigator
- •3) Have one or more measurable target lesions on MRI before treatment starts.
- •4) Severe disability or refractory symptoms depending on target disease
- •5) Have sufficient liver, kidney and heart functions at the time of registration
- •6) Written consent to participate in this clinical trial has been given by the subject in person or by a legal guardian (when the subject is younger than 20 years at consent).
排除标准
- •1) Patients who have received a targeted drug related to the mTOR pathway within 8 weeks before the start of study drug administration.
- •2) Patients with infections that require systemic treatment.
- •3) Patients with a Karnofsky PS score of 30 or less (10 years or older) or Lansky play-PS of 30 or less (under 10 years) due to permanent sequelae due to cerebral disorders.
- •4) Patients with any of the following complications:
- •Uncontrolled diabetes, Uncontrolled hypertension, Uncontrolled hyperlipidemia, Severe liver disease, Severe renal disease
- •5) Patients receiving long-term immunosuppressive drugs (cyclosporine, tacrolimus, etc.) or steroids (4 weeks or more) at the time of registration.
- •6) Patients who require administration of a drug that affects CYP3A4 activity one week before starting sirolimus administration.
- •7) Patients with immunodeficiency such as HIV and primary immunodeficiency.
- •8) Patients who are carriers of hepatitis B virus and / or carriers of hepatitis C virus.
- •9) Patients who have undergone surgery (resection, sclerotherapy, endovascular treatment) for the target lesion within 2 weeks before obtaining consent.
- •10) Patients who have received a therapeutic drug (propranolol, Eppikajutsuto, Tokikenchuto, interferon, octreotide, bisphosphonate, denosumab, etc.) for the target disease within 2 weeks before obtaining consent.
- •11) Patients who received myelosuppressive chemotherapy, biologics, drugs not covered by insurance, etc. within 4 weeks before obtaining consent.
- •12) Patients who received radiotherapy for the target lesion within 24 weeks before obtaining consent.
- •13) Patients who meet any of the following.
- •may be pregnant or pregnant, lactating, Disagree with contraception during this study
- •14) If administering tablets, persons diagnosed with lymphangioma, lymphangiomatosis, or Gorham's disease.
- •15) In addition, patients whose investigator / assigning doctor determines that participation in this study is inappropriate.
研究者
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