Efficacy and Safety of SP-8203 in Patients With Ischemic Stroke Requiring rtPA

• Status: Completed
• Trial end date: 2020-12-20
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (Otaplimastat) and recombinant tissue Plasminogen Activator (rtPA) standard of care. In this clinical trial, rtPA will be injected intravenously using an infusion device. If reperfusion is not occur in spite of rtPA therapy, endovascular therapy can be performed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shin Poong Pharmaceutical Co. Ltd.
• Treatments: Otaplimastat

Criteria

Inclusion Criteria:

• Patients with neurologic deficit of ≥ 4 points by NIHSS score

• Adults aged ≥19 years and ≤85 years. (Pre-stroke mRS must be 0 or 1; No significant pre-stroke disability)

• Subjects who can receive rtPA therapy within 4.5 hours after the onset of early symptoms of acute ischemic stroke.

• Subjects available for brain MRI (DWI, GRE/Susceptibility Weighted Imaging (SWI), FLAIR, MRA) scanning

• Subjects who consent to participate in this trial.

Exclusion Criteria:

• Patients with systemic allergic diseases or hypersensitivity to specific drugs.

• Patients who were diagnosed with myocardial infarction (MI) within the last 6 months.

• Patients who had arrhythmia causing clinical symptoms such as dyspnea or palpitation within the last 6 months.

• Patients showing the following abnormal ECG findings in stable condition at Emergency Room:

• The range of pulse rate - under 55/min or exceed 120/min

• 2nd or 3rd degree Atrioventricular (AV) block indicated in ECG

• Congenital or acquired QT syndrome indicated in ECG

• Pre-excitation syndrome indicated in ECG

• Patients with severe heart failure of New York Heart Association (NYHA) Class III or Class IV.

• Patients with fever (≥ 38℃) or infection signs which require antibiotic therapy at screening.

• Patients with pulmonary diseases (asthma, Chronic Obstruction Pulmonary disease, and active tuberculosis etc.) who have being recently been treated more than 1 month at screening.

• Patients with decreased hemoglobin (Hb< 10g/dL), decreased platelet count (PLT< 100,000/mm3) or hematocrit of <25% in complete blood count.

• Patients who have undergone hemodialysis and/or treatments due to nephropathies, acute or chronic renal failure at screening.

• Patients with a cancer in following conditions: diagnosed within 6 months before the screening time, or any treatment for cancer within the previous 6 months, or with recurrent/ metastatic cancer.

• Pregnant and lactating women. However, women of childbearing age can participate in the trial only when non-pregnancy is confirmed. Woman of childbearing age is defined as woman who is not definitely menopause and did not receive a surgical contraception.

• Patients who do not consent to use double barrier contraception during the trial period.

• Patients who have participated in other clinical trials of other drugs within the past 3 months. However, if they participated in observational studies and did not take drugs, they can participate in this trial.

• Patients who cannot participate in the trial according to the judgment of investigators.

• Those who cannot be administered with rtPA.