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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02515838
• Date of registration: 27/07/2015
• Prospective Registration: No
• Primary sponsor: Modus Therapeutics AB
• Public title: Sevuparin Infusion for the Management of Acute VOC in Subjects With SCD
• Scientific title: 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).
• Date of first enrolment: July 2015
• Target sample size: 147
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02515838
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Bahrain, Jamaica, Lebanon, Netherlands, Oman, Saudi Arabia, Turkey

Contacts

• Name: Dr Bart J Biemond, MD, PhD
• Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sickle-Cell Disease

Intervention(s)

Drug: Sevuparin

Other: Placebo

Primary Outcome(s)

Time to resolution of VOC [Time Frame: From hospitalisation until discharge, defined as freedom from parenteral opioid use and readiness for discharge i.e. from randomisation until day 7]

Secondary Outcome(s)

Duration of severest pain, [Time Frame: From baseline (visit 1) until day 3-7]

Mean change in pain intensity [Time Frame: From baseline (visit 1) until day 3-7]

Pharmacokinetic (PK) characteristics of sevuparin [Time Frame: Pre dose, 1h, 2h, 24h, 1/day (day 3-8)]

Frequency and pattern of treatment-emergent adverse event (TEAEs) [Time Frame: Time from start randomsiation until end of study, approximately 1 month 1 week after randomisation]

Cumulative dose of parenteral opioids [Time Frame: From baseline (visit 1) until day 3-7]

Secondary ID(s)

TVOC01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ergomed