A Phase I, open-label, multi-center, pharmacokinetic, pharmacodynamic and safety study of tenecteplase in adult patients with acute ischemic stroke

Roche (United States)0 个研究点目标入组 20 人开始时间: 2022年5月16日最近更新: 2022年5月30日

试验速览

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•1. Age =18 years at the time of signing the Informed Consent Form
•2. Clinical diagnosis of AIS based on signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke, the persistence of neurologic deficit(s), and findings on computed tomographic (CT) scan or magnetic resonance imaging (MRI) with gradient echo sequences (GRE) sequence of the brain supportive of an AIS diagnosis
•3. Time from symptom onset to study drug administration is <4.5 hours

•1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 30 days after tenecteplase administration
•2. Active internal bleeding; evidence of intracranial haemorrhage on neuroimaging at screening
•3. Gastrointestinal haemorrhage within 21 days of screening
•4. Known hereditary or acquired haemorrhagic diathesis or coagulation factor deficiency
•5. Use of one of the novel oral anticoagulants, such as direct thrombin inhibitors or direct factor Xa inhibitors, within the last 48 hours (e.g., dabigatran, rivaroxaban, apixaban, edoxaban)
•6. Treatment with a thrombolytic within the last 3 months prior to dosing
•7. Intracranial neoplasm (except small meningioma), arteriovenous malformation, or aneurysm
•8. History of malignancy, including solid tumour and haematological malignancies, except basal cell carcinoma, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix that has been previously completely excised with documented, clear margins
•9. Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg)
•10. Clot retrieval attempted using a neurothrombectomy device prior to dosing
•11. History of acute ischemic stroke in the last 90 days
•12. History of haemorrhagic stroke
•13. Intracranial or intraspinal surgery or trauma within 2 months

发起方

Roche (United States)