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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reprixys Pharmaceutical Corporation; Selexys Pharmaceuticals Corporation
• Collaborators: Food and Drug Administration (FDA); National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Hydroxyurea

Criteria

Key Inclusion Criteria:

• Sickle Cell Disease (HbSS, HbSC, HbSβ⁰-thalassemia, or HbSβ⁺-thalassemia)

• If receiving hydroxyurea or erythropoietin, treatment must have been prescribed for at least 6 months, with the dose stable for at least 3 months

• Between 2 and 10 sickle cell-related pain crises in the past 12 months

Key Exclusion Criteria:

• On a chronic transfusion program or planning on exchange transfusion during the study

• Hemoglobin <4.0 g/dL

• Planned initiation, termination, or dose alteration of hydroxyurea during the study

• Receiving chronic anticoagulation therapy (e.g. warfarin, heparin) other than aspirin