Status:
COMPLETED
Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises
Lead Sponsor:
Reprixys Pharmaceutical Corporation
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Food and Drug Administration (FDA)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief 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 redu...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT01895361
Start Date
July 1 2013
End Date
March 1 2016
Last Update
January 31 2020
Active Locations (56)
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1
Birmingham, Alabama, United States
2
Mobile, Alabama, United States
3
Little Rock, Arkansas, United States
4
Los Angeles, California, United States