Sickle Cell Pain Crisis Management Study (SUSTAIN) – Phase II

Study to Assess Safety and Efficacy of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients with Sickle Cell-Related Pain Crises (SUSTAIN)

Protocol Description

Through this study researchers hope to determine whether the investigational drug SelG1 is effective in preventing or reducing the occurrence of pain crises when given to patients with sickle cell disease. The study will include and compare results for participants who are being treated with hydroxyurea and those who are not. 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, which can be acute and last from hours to days.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting participants of both genders between the ages of 18 and 65 who have sickle cell disease and who have experienced sickle cell-related pain crises within the past year.
Males: 18 to 65 years old
Females: 18 to 65 years old

Requirements

Following initial screening, which will include a physical and blood testing, participants will be placed into one of three study groups: one that takes a high-dose of SelG1, one that takes a low-dose, and one that takes a placebo. The study drug will be administered via intravenous infusion over approximately 30 minutes, and patients will be monitored for an additional hour after the infusion. The drug will be given on days 1 and 15 and then once every 4 weeks for a total of 14 administrations. A follow up visit with additional tests will occur at week 58.
Visits: 16
Duration: Approximately 14 months

Status: Open for Enrollment

Source(s) of Support

Selexys Pharmaceuticals Corp.

Primary Investigator

Debra Cohen, MD

Contact Information

For information about the study or enrollment, please contact:
Study Coordinator Angela Martino, BSN, RN
412-692-6467