The assessment of effectiveness and safeness of utilizing empagliflozin in the treatment of neutropenia of patients suffering from glycogenolysis type Ib - EMPAtia

The Children’s Memorial Health Institute0 个研究点目标入组 20 人开始时间: 2021年4月19日最近更新: 2022年3月14日

适应症

试验速览

暂无简介。

•The patients meeting all the criteria listed below will be included into the research:
•- men and women
•- older than 4 weeks
•- biochemically and / or molecularly diagnosed glycogenosis Ib with neutropenia and / or abnormal NADPH oxidase activity in neutrophils
•- expressing voluntary and informed consent by a statutory representative in the case of children below 13 years of age, a statutory representative and a patient in the case of children above 13 years of age and by a patient himself in the case of adult patients.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 20
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 4
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•5.The following patients will not be included into the research:
•- patients who are suspected of not cooperating, including the patients not arriving for follow-up examinations or not following dietary recommendations;
•- suffering from chronic kidney disease with Estimated Glomerular Filtration Rate < 60 ml/min/1.73 m2
•- suffering from urinary tract infection at the time of qualifying for the research (time criterion at the time of inclusion into the research, until the urinary tract infection treatment is concluded),
•- participating in other clinical trials (grace period: 6 months counting from the conclusion of participation in other trials to the date of signing the Informed Consent Form),
•- participating in other forms of medicinal experiments apart from the experimental
•empagliflozin treatment (grace period: 24 months counting from the date of concluding participation in the experiment to the date of signing the Informed Consent Form).
•- allergic to the administered drugs
•- pregnant and breast-feeding women
•- patients who did not give consent for participation in the research

发起方

The Children’s Memorial Health Institute