NL-OMON52585已完成4 期
A multicenter, open-label post authorization safety study to evaluate the effect of LysaKare® infusion on serum potassium levels in GEP-NET patients eligible for Lutathera® treatment - Lysakare PASS (0050/0870)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
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
- 18 至 99（—）
入选标准
- •1. Male or female patients with somatostatin receptor positive
- •gastroenteropancreatic neuroendocrine tumours (GEP-NETs), who are eligible for
- •the treatment with Lutathera® as per Lutathera® label indication.
- •2. Age *18 years.
- •3. Patients who have provided a signed informed consent form to participate in
- •the study, obtained prior to the start of any protocol related procedures.
排除标准
- •1. Pre-existing hyperkalemia (>6.0 mmol/L at screening) if not adequately
- •corrected before starting the LysaKare® infusion.
- •2. Instances when Lutathera® is not recommended per the Lutathera® SmPC:
- •a. Uncontrolled congestive heart failure (NYHA III, IV);
- •b. Kidney failure with creatinine clearance < 50 mL/min calculated by the
- •Cockroft Gault method;
- •c. Impaired haematological function with either Hb < 4.9 mmol/L (8 g/dL),
- •platelets < 75 G/L (75x103/mm3), or leucocytes < 2 G/L (2,000/mm3) (except
- •lymphopenia);
- •d. Liver impairment with either total bilirubinemia > 3 times the upper limit
- •of normal or albuminemia < 30 g/L and prothrombin ratio decreased < 70%.
- •3. Pregnancy or lactation, positive pregnancy test at screening or pre-dose
- •based on the contraindication for Lutathera®.
- •4. Hypersensitivity to the IMP active substances.
- •5. Any significant medical or social condition which may interfere with the
- •subject*s ability to comply with the study visit schedule or the study
- •assessments.
- •6. Patients who have received any investigational agent within the last 30 days.
- •7. Patients that have received a dose of Lutathera® prior to the screening
- •visit or are scheduled for Peptide Receptor Repeat (PRRT) treatment within 7
- •days of the study infusion of LysaKare®.
研究者
相似试验
进行中（未招募）
1 期
Post-Authorization Safety Study (PASS) of LysaKare® in adult GEP-NET patients.EUCTR2019-004073-76-ITAdvanced Accelerator Applications SA40
进行中（未招募）
1 期
Post-Authorization Safety Study (PASS) of LysaKare® in adult GEP-NET patients.EUCTR2019-004073-76-PLAdvanced Accelerator Applications International SA40
进行中（未招募）
1 期
Post-Authorization Safety Study (PASS) of LysaKare® in adult GEP-NET patients.EUCTR2019-004073-76-NLAdvanced Accelerator Applications International SA40
已完成
不适用
A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO´s Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG)Primary open-angle glaucomaPER-168-08OPKO Health Inc.,
尚未招募
不适用
A Study to Assess the Safety and Efficacy of Remdesivir in COVID-19 infected Indian patientsCTRI/2021/12/039011Jubilant Generics Limited