NL-OMON21411招募中不适用
A Non-Interventional Mechanistic Study to Characterize Biomarkers for Mitochondrial Dysfunction and Inflammation in Subjects with Mitochondrial Disorder and Cardiomyopathy, and Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
研究概览
简要总结
.A.
入排标准
入选标准
- •All subjects
- •1. Adults between 18 and 75 years, inclusive at screening
- •2. Body mass index (BMI) 18.0 to 30.0 kg/m2, inclusive at screening
- •3. Ability and willingness to abstain from alcohol at study visit
- •4. Subject (and/or parent/legal guardian) has voluntarily signed consent form.
- •5. Willingness and ability to comply with all study procedures.
- •6. Ability to communicate with the investigator in Dutch or English
- •Subjects of cohort 1 with Mitochondrial Disorder (in addition)
- •7. Diagnosis of Mitochondrial Disorder, confirmed by:
- •a. Genetic testing at any time prior to screening showing m.3243A>G mutation
- •b. Newcastle Mitochondrial Disease Scale (NMDAS) score =11
- •8. Current cardiomyopathy documented as:
- •Left ventricular hypertrophy (LVH) on echocardiography (defined as interventricular septal thickness (IVS) / left
- •ventricular posterior wall thickness (LVPW)) = 11mm or LV mass indexed = 115 g/m2
- •Subjects of cohort 2 Healthy Volunteers (in addition)
- •9. Judged to be in good health in the opinion of the Investigator on the basis of a medical evaluation that reveals
- •the absence of any clinically relevant abnormality
- •10. Matching to MitoD group for age (+/- 5 years), gender, and BMI (+/- 3 kg/m2).
排除标准
- •2. Women with positive urine hCG test at screening
- •3. Subject has a hemoglobin values outside the normal limits (as per local lab)
- •4. Subject has received drug therapy with any cytostatic, sGC stimulator/activator or nitrate agent during the last 3 months
- •5. Subjects with evidence of arterial hypertension
- •6. Subjects with severe aortic valve stenosis
- •7. Subject has received drug therapy with Metformin during last 3 months
- •8. Significant psychiatric or neurological disorder that would inhibit the subject from being compliant with study procedures
- •14. Positive nasopharyngeal rapid antigen test for SARS-CoV-2 at admission to the clinical research center
- •15. Subject has received any vaccination in the last 2 weeks prior to Visit 1
- •Subjects of cohort 2 Healthy Volunteers (in addition)
- •16. Subject has acute decompensated hepatic, gastrointestinal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders.
研究者
相似试验
已完成
不适用
A Non-Interventional Mechanistic Study to Characterize Biomarkers for Mitochondrial Dysfunction and Inflammation in Subjects with Mitochondrial Disorder and Cardiomyopathy, and Healthy Volunteersenergy metabolism diseasemitochondrial diseases1001928010027424cardiomyopathyNL-OMON51060OMEICOS Therapeutics GmbH16
招募中
不适用
Metformin Intestinal Prospective StudydiabetesJPRN-jRCT1051210063Sakaguchi Kazuhiko30
进行中（未招募）
1 期
This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients.Active ulcerative colitisMedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856EUCTR2017-000100-20-GBBoehringer Ingelheim Limited10
进行中（未招募）
1 期
This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients.EUCTR2017-000100-20-BESCS Boehringer Ingelheim Comm. V10
已完成
不适用
Non-interventional Study of Ectoin Nasal Douche (END01) in Patients With Acute Viral RhinosinusitisAcute RhinosinusitisNCT03480100Bitop AG120