Conditions: Sickle Cell Disease
Keywords: SelG1 P-selectin monoclonal antibody sickle cell disease sickle cell anemia sickle cell pain crisis pain crises vasoocclusion vaso-occlusion priapism hepatic sequestration splenic sequestration chest syndrome SCD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 198
Healthy volunteers: no

Brief summary:
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)

Detailed description:

Arms:
arm 1: IV Infusion, once every 4 weeks through Week 50 arm 2: IV Infusion, once every 4 weeks through Week 50 arm 3: IV Infusion, once every 4 weeks through Week 50

Interventions: intervention 1: SelG1 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: