Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises
| Status: | Completed |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 16 - 65 |
| Updated: | 10/4/2017 |
| Start Date: | July 2013 |
| End Date: | March 2016 |
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 Sickle Cell-Related Pain Crises
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)
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)
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
We found this trial at
50
sites
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Washington, D.C., District of Columbia
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