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).
This will be a phase II, multi-centre, randomized, double-blind, placebo-controlled study designed to assess preliminary efficacy, safety and pharmacokinetics (PK) of 2-7 days continuous IV administration of sevuparin for the management of acute VOC in subjects with SCD. Adults and adolescents ≥ 12 years of age will be randomized to treatment with sevuparin or placebo (ratio 1:1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
147
Salmaniya Hospital, Kingdom of Bahrain
Manama, Bahrain
Salmaniya Medical Complex, Bahrain
Manama, Bahrain
Time to resolution of VOC
Time from start of infusion until resolution of VOC crisis/episode
Time frame: From hospitalisation until discharge, defined as freedom from parenteral opioid use and readiness for discharge i.e. from randomisation until day 7
Frequency and pattern of treatment-emergent adverse event (TEAEs)
All events to be reported from randomization until end of study
Time frame: Time from start randomsiation until end of study, approximately 1 month 1 week after randomisation
Pharmacokinetic (PK) characteristics of sevuparin
PK characteristics of sevuparin during and after administration of sevuparin as a continuous IV infusion (subgroup) ◦Area under the plasma concentration versus time curve (AUC) of Sevuparin.
Time frame: Pre dose, 1h, 2h, 24h, 1/day (day 3-8)
Mean change in pain intensity
VAS (visual analog scale) every fourth hour. Range from 0 (no pain) to 100 (max pain)
Time frame: From baseline (visit 1) until day 3-7
Duration of severest pain,
Defined as time to a 30% reduction in pain intensity (VAS)
Time frame: From baseline (visit 1) until day 3-7
Cumulative dose of parenteral opioids
Total dose of parenteral opioids
Time frame: From baseline (visit 1) until day 3-7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Annotto Bay Hospital
Annotto Bay, Jamaica
Kingston Public Hospital
Kingston, Jamaica
University Hospital of the West Indies
Kingston, Jamaica
Winchester Surgical and Medical Institute
Kingston, Jamaica
Mandeville Regional Hospital
Mandeville, Jamaica
May Pen Public Hospital Clarendon
May Pen, Jamaica
Cornwall Regional Hospital, Jamaica
Montego Bay, Jamaica
American University of Beirut Medical Center, Beirut, Cairo street, Beirut, Lebanon
Beirut, Lebanon
...and 10 more locations