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

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to investigate Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis (VOC) in Subjects with Sickle-Cell Disease (SCD).

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

Details

• Lead Sponsor: Dilaforette AB; Modus Therapeutics AB
• Collaborator: Ergomed

Criteria

Inclusion Criteria:

• Sign a written informed consent (adults, parents) and assent (adolescents)

• Male or female, age 12-50 years.

• Diagnosis of Sickle cell disease

• Subjects admitted for an acute, painful VOC to be treated/or treated with parenteral opioid analgesia.

• Expectancy of need for hospitalization during at least 48 hours.

• Be at least 1 year postmenopausal, surgically sterile, or if Women of Child Bearing Potential (WOCBP), e.g. following menarche practicing an effective method of birth control

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.