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Hydroxyurea with or without Clotrimazole in Sickle Cell Anemia
NCT00004492Phase 2
Key facts
- Status
- Completed
- Start
- Oct 1999
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- clotrimazole
- Conditions
- sickle cell anemia (SCA)
01
Overview
Phase 2, randomised, open-label trial of clotrimazole in sickle cell anemia (SCA) (2 arms). Primary endpoints: Severity of anemia at 12 months and Rate of hemolysis at 12 months. Started Oct 1999; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Hydroxyurea + Clotrimazole
Oral hydroxyurea and oral clotrimazole daily for 12 months.
Hydroxyurea Alone
Oral hydroxyurea daily for 12 months.
03
Who it enrols
Patients with sickle cell anemia on a stable dose of hydroxyurea for at least 3 months, with specific hematologic and organ function criteria.
04
Endpoints
Primary
Severity of anemia
Rate of hemolysis
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