JPRN-jRCT2051200032进行中（未招募）3 期
A long-term study of NPC-12G gel in neurofibromatosis type I
Kaneda Mari0 个研究点目标入组 100 人开始时间: 2020年7月6日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- >= 3age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Patients diagnosed as neurofibromatosis type 1 based on the clinical diagnostic criteria in guideline of Japanese Dermatological Association
- •2)Patients participated in a Phase II/III investigator-initiated clinical trial for neurofibromatosis type I (OSD-001-004) who wish to continue treatment of the study drug
- •3)At the time of enrollment, patients who are able to choose ten evaluable target lesions for efficacy (at least 5)..
- •4)Patients who have evaluable skin neurofibromas at baseline.
- •5)Males and females who are 3 years old or elder at the time of informed consent.
- •6)Patients who (or whose guardian) give a written informed consent in understanding and
- •willingness after having received enough explanation regarding the study participation.
- •7)Patients whose use or continued use of the study drug is judged to be reasonable by the principal investigator or sub-investigator.
排除标准
- •1)Patients who occurred serious adverse effects, who discontinued the sudy due to adverse effects, or who discontinued the sudy due to withdrew of their consent in the Phase II/III investigator-initiated study of neurofibromatosis type I (OSD-001-004)
- •2)Patients with abnormal findings (e.g., pneumonia) in the results of chest x-ray at the time of screening
- •3)Patients with creatinine clearance of less than 50 mL/min
- •4)Patients with poorly controlled dyslipidemia (serum triglycerides >500 mg/dL or LDL cholesterol >190 mg/dL even with treatment)
- •5)Patients who have complications such as infection, cardiac, hepatic, pulmonary, renal, or hematological diseases and malignant tumors that are considered unsuitable for participation in this study.
- •6)Patients with alcohol sensitivity or allergy to an ingredient of the study drug (Sirolimus)
- •7)Female patients who are pregnant, may be pregnant, or are lactating
- •8)Patients (including male patients with a fertile partner) who cannot consent to use adequate contraception from the date of consent to 12 weeks after the end of treatment
- •9)Patients who participated in any other clinical trial or clinical study, other than the OSD-001-004 study, and have taken an investigational or clinical study drug within 6 months prior to the date of the consent
- •10)Patients who are participating in an observational study during this clinical study
- •11)Patients who are considered by the investigator as unsuitable for participation in this clinical study
研究者
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