Sickle Cell Anemia Clinical Trial
OBJECTIVES:
I. Compare the efficacy of hydroxyurea with or without clotrimazole in terms of limiting the
severity of anemia and the rate of hemolysis in patients with sickle cell anemia.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of sickle cell anemia confirmed by hemoglobin electrophoresis Received hydroxyurea for at least 6 months On a stable dose for at least 3 months Tolerating dose of at least 5 mg/kg/day --Prior/Concurrent Therapy-- Chemotherapy: - No other concurrent antisickling agent Other: No concurrent drug that may interact with or influence the metabolism of hydroxyurea or clotrimazole --Patient Characteristics-- Hematopoietic: WBC at least 4000/mm3 Platelet count at least 150,000/mm3 Hemoglobin less than 11 g/dL Hepatic: AST/ALT no greater than 100 units/L Renal: Creatinine no greater than 1.5 mg/dL Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No prior adverse reaction to hydroxyurea or clotrimazole - No recent or progressive neurologic dysfunction |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina School of Medicine | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina |
United States,
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04134299 -
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease
|
N/A | |
Completed |
NCT04581356 -
Voxelotor Sickle Cell Exercise Study
|
Phase 4 | |
Completed |
NCT02712346 -
The Role of Endothelin-1 in Sickle Cell Disease
|
Phase 1 | |
Completed |
NCT01976416 -
Novel Use Of Hydroxyurea in an African Region With Malaria
|
Phase 3 | |
Withdrawn |
NCT02162225 -
Study of Beet Juice for Patients With Sickle Cell Anemia
|
Phase 2 | |
Completed |
NCT01137721 -
State Of The Art Functional Imaging In Sickle Cell Disease
|
||
Withdrawn |
NCT00937144 -
Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil
|
Phase 4 | |
Terminated |
NCT01350232 -
Treatment of Sickle Cell Anemia With Stem Cell Transplant
|
N/A | |
Completed |
NCT00512564 -
Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia
|
N/A | |
Completed |
NCT00512226 -
Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia
|
N/A | |
Completed |
NCT00004143 -
Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes
|
Phase 2 | |
Completed |
NCT00004412 -
Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers
|
Phase 2 | |
Withdrawn |
NCT01925001 -
Phase 2 Study of MP4CO to Treat Vaso-occlusive Sickle Crisis
|
Phase 2 | |
Completed |
NCT01783990 -
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
|
||
Completed |
NCT01848691 -
Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis
|
N/A | |
Completed |
NCT00874172 -
Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy
|
N/A | |
Completed |
NCT01000155 -
Efficacy of Vorinostat to Induce Fetal Hemoglobin in Sickle Cell Disease
|
Phase 2 | |
Completed |
NCT00236093 -
Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain
|
Phase 2 | |
Completed |
NCT00399074 -
Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia
|
Phase 3 | |
Completed |
NCT02065596 -
Hematopoietic Stem Cell Transplant for Sickle Cell Disease
|
Phase 1 |