Sevuparin Infusion for the Management of Acute VOC in Subjects With SCD

Exclusion Criteria

• •Severe hepatic failure/disease, abnormal liver enzyme tests or history of hepatitis B virus (HBV), hepatitis C virus (HCV)
• •Abnormal conjugated (direct) bilirubin 3 fold above ULN
• •History of clinically significant bleeding in vital organs
• •Current clinically significant bleeding, as judged by the investigator
• •Current use of acetylsalicylic acid (ASA), anti-platelet therapy, anticoagulant therapy
• •Abnormal coagulation laboratory values
• •A platelet count \<75,000/µL.
• •BMI \>35
• •Subjects with more than 5 hospitalizations for VOC during the last 6 months
• •Evidence of acute SCD complications other than VOC at screening
• •The use of strong opioids for \> 3 consecutive days during the last 15 days before presenting to the hospital
• •History of chronic drug abuse.
• •Renal dysfunction
• •Known infection (positivity) with human immunodeficiency virus (HIV), HBV or HCV.
• •Significant ECG abnormality
• •History of a clinically significant drug allergy to heparin, LMWH's, sevuparin, or morphine.
• •Use of any investigational agent during the 30 days prior to the first dose.
• •For females: pregnancy, lactating or intention of becoming pregnant
• •Evidence of clinically significant disorders that might interfere with the study aim or safety of the subject
• •Any condition that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study.