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
Description
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)
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.Inclusion and Exclusion 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
Sites
Please contact Gangothri Namasivayam to learn more about where you can participate in this trial. Please use the contact form on the right side.
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