Clinical Trial
Study Details
The Drug Product sevuparin solution for IV infusion
Placebo for IV infusion
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).
Study Overview
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).
Contacts and Locations
Salmaniya Hospital, Kingdom of Bahrain
Manama
Bahrain
Salmaniya Medical Complex, Bahrain
Manama
Bahrain
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
Nini Hospital
Tripoli
Lebanon
Dept of Haematology
Amsterdam
Netherlands
Erasmus MC
Rotterdam
Netherlands
Sultan Qaboos University Hospital Alkhodh, Oman
Muscat
Oman
Sultan Qaboos University
Muscat
Oman
King Fahd Medical City, As Sulimaniyah, Riyadh Saudiarabien
Riyadh
Saudi Arabia
King Saud University, Riyadh, Saudiarabien
Riyadh
Saudi Arabia