Clinical study of sirolimus about safety for Japanese patients: Shizuoka 2019-1 (Sirolimus Shizuoka 2019-1)

未提供0 个研究点目标入组 5 人开始时间: 2019年8月9日最近更新: 2022年9月26日

适应症

试验速览

暂无简介。

•After completion of clinical trial (FCDS-01) in Shizuoka MINDs, Age, 6-65 years old; bodyweight >= 20Kg
•Improvement of epileptic seizures by FCDS-01
•No severe adverse effect by sirolimus or antiepileptic drugs in preceding clinical trial (FCDS-01)
•Informed consent by written agreement after precise explanation

•Patients without accurate data of compliance, adverse event, seizure frequency, duration of seizure
•Possible attendance another clinical trial
•Prescription of PB or VGB
•Possible ketogenic diet therapy
•Pregnant patient or no agreement for contraception
•Basic disease inflammation, degenerative diseases,
•Risk of suicide
•History of alcoholic abuse
•Among preceding clinical trial (FCDS-01), the following laboratory data were observed
•9-1 AST or ALT >= 2.5 folds of standard value in our hospital
•9-2 WBC < 3000 /mm3, Ht < 30%, Platelet < 80000/mm3, neutrophils < 1000/mm3
•9-3 C cr < 50ml/min, eGFR < 30mL/min/1.73m2
•9-4 HBsAg (+), HBs Ab(+) after HBV infection, HBc Ab (+)
•9-5 Uncontrolled hyperlipidemia
•Association of arrythmia or cardiac failure requiring treatment.
•Association of immunodeficiency
•Irregular visit to hospital
•Decision of inappropriate patient for this study by responsible doctor

adverse event

未报告次要终点

发起方

未提供