Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises
Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises
The purpose of this study was to determine whether the investigational drug SelG1 when given
 to sickle cell disease patients either taking or not taking hydroxyurea was effective in
 preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the
 bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may
 prevent small blood vessels from becoming blocked and therefore reduce the occurrence and
 severity of pain crises. Other effects of SelG1 was evaluated, as well as the safety of the
 drug and how long it stayed in the blood stream.

 Funding Source - FDA Office of Orphan Products Development (OOPD)
Key Inclusion Criteria:

 -  Sickle Cell Disease (HbSS, HbSC, HbSβ⁰-thalassemia, or HbSβ⁺-thalassemia)

 -  If receiving hydroxyurea or erythropoietin, treatment must have been prescribed for at
 least 6 months, with the dose stable for at least 3 months

 -  Between 2 and 10 sickle cell-related pain crises in the past 12 months

 Key Exclusion Criteria:

 -  On a chronic transfusion program or planning on exchange transfusion during the study

 -  Hemoglobin <4.0 g/dL

 -  Planned initiation, termination, or dose alteration of hydroxyurea during the study

 -  Receiving chronic anticoagulation therapy (e.g. warfarin, heparin) other than aspirin