Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises

Phase 2 Completed 198 enrolled Reprixys Pharmaceutical Corporation Food and Drug Administration (FDA) · collab National Heart, Lung, and Blood Institute (NHLBI) · collab

RandomizedParallel-groupQuadruple-blindTreatment

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)

Timeline

Start: 2013-07
Primary completion: 2016-03
Completion: 2016-03

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Crizanlizumab	Monoclonal antibody	2.5 mg/kg	Intravenous
Subject	Crizanlizumab	Monoclonal antibody	5 mg/kg	Intravenous

Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises

Summary

Timeline

Publications

Drugs

Indications