A Phase IIa: single ascending dose safety, tolerability and pharmacokinetic study of NicaPlant® in aneurysmal subarachnoid haemorrhage patients undergoing aneurysm clipping

BIT Pharma GmbH0 个研究点目标入组 14 人开始时间: 2017年12月6日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•1. Informed consent is obtained.
•2. Male or female patients aged 18 to 75 years (inclusive).
•3. Federation of Neurosurgery (WFNS) grade I-IV or Hunt & Hess grade I-IV.
•4. Ruptured saccular aneurysm, confirmed by angiography.
•5. Onset of aSAH clinical symptoms within the preceding 48 hours.
•6. Treatment of aneurysm via surgical clip ligation within 72 hours of aSAH is achievable.
•7. Female patients of child-bearing potential must have a negative pregnancy test (urine or serum) at screening and must agree to use adequate birth control during the study and up to 2 months after implantation of the study drug. Female patients are considered to be not of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of 2 years without a natural menstrual cycle. Male patients must agree to use adequate birth control during the study and up to 4 months after implantation of the study drug.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 7
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•1. SAH due to other causes (e.g. trauma, fusiform or mycotic aneurysm).
•2. Pregnant or lactating Women.
•3. Federation of Neurosurgery (WFNS) grade V or Hunt & Hess grade V.
•4. Intraventricular or intracerebral blood, in the absence of subarachnoid blood.
•5. Treatment of aneurysm via endovascular embolization.
•6. Presence of moderate or severe vasospasm on screening angiography.
•7. Any known or CT evidence of previous major cerebral damage.
•8. Evidence of a cerebral infarction with neurological deficit on pre-treatment CT.
•9. History of malignant disease (except for non-melanoma skin cancer) within the previous 5 years or any history of malignant brain tumours or brain metastasis.
•10. Patients who have received an investigational product or participated in another interventional clinical study within 30 days prior to randomisation.
•11. Kidney disease as defined by plasma creatinine =2.5mg/dL (221µmol/L); liver disease as defined by total bilirubin >3mg/dL (513µmol/L); and/or known diagnosis or clinical suspicion of liver cirrhosis.
•12. Patients with known allergy for Poly (D,L-lactide-co-glycolide) (PLGA) or nicardipine.
•13. Major complication during aneurysm repair such as, but not limited to, massive intraoperative haemorrhage, brain swelling, or inability to secure the ruptured aneurysm.

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