Clinical Trial: Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Blind, 12-Month Study to Assess Safety and Efficacy of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Si
Brief Summary:
The purpose of this study is to determine whether the investigational drug SelG1 when given to sickle cell disease patients either taking or not taking hydroxyurea is 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 will also be evaluated, as well as the safety of the drug and how long it stays in the blood stream.
Funding Source - FDA Office of Orphan Products Development (OOPD)
Detailed Summary:
Sponsor: Reprixys Pharmaceutical Corporation
Current Primary Outcome: Rate of sickle cell-related pain crises [ Time Frame: One year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Rate of sickle cell-related pain crises by concomitant hydroxyurea use [ Time Frame: One year ]
- Time to first sickle cell-related pain crisis [ Time Frame: Up to one year ]
- Time to second sickle cell-related pain crisis [ Time Frame: Up to one year ]
- Number of hospitalization days per year [ Time Frame: Up to one year ]
- Absolute change from baseline in hemoglobin [ Time Frame: One year ]
- Absolute change from baseline in lactate dehydrogenase [ Time Frame: One year ]
Original Secondary Outcome: Same as current
Information By: Reprixys Pharmaceutical Corporation
Dates:
Date Received: July 3, 2013
Date Started: July 2013
Date Completion:
Last Updated: May 4, 2017
Last Verified: May 2017
