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

Completed · Phase 2 · Has a placebo group

Conditions studied: Sickle Cell Disease

In brief

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 facts

Study ID

NCT01895361

Run by

Reprixys Pharmaceutical Corporation

People needed

198

Starts

2013-07-01

Expected to finish

2016-03-01

Last updated by the study team

2020-01-31

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — Sacramento, California, United States
• Study site — Aurora, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Bethesda, Maryland, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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