Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
FDA Office of Orphan Products Development Children's Hospital Boston |
---|---|
Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004404 |
OBJECTIVES:
Determine the effectiveness of the combined use of clotrimazole and hydroxyurea on a specific panel of red cell characteristics in patients with sickle cell syndromes.
Condition | Intervention |
---|---|
Sickle Cell Anemia |
Drug: clotrimazole Drug: hydroxyurea |
Study Type: | Interventional |
Study Design: | Treatment |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Sickle cell syndromes characterized by vaso-occlusive crises sufficiently severe to require prophylactic therapy Three or more crises per year sufficiently severe to require hospitalization Stable dose of hydroxyurea for at least 4 months required --Prior/Concurrent Therapy-- No treatment with any other antisickling agents within the past 4 months Biologic therapy: No transfusion within 90 days No concurrent chronic transfusions allowed (defined as more than one transfusion per month for 2 or more months) Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No chronic medications that alter neurologic, renal, or hepatic functions
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Kenneth R Bridges 617-432-1000 | |
Children's Hospital - Boston | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Carlo Brugnara 617-355-6347 |
Study Chair: | Carlo Brugnara | Children's Hospital Boston |
Study ID Numbers: | 199/13288, CH-B-97-052, CH-B-FDR001022 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004404 History of Changes |
Health Authority: | United States: Federal Government |
genetic diseases and dysmorphic syndromes hematologic disorders rare disease sickle cell anemia |
Hydroxyurea Hematologic Diseases Clotrimazole Miconazole Tioconazole Anemia Rare Diseases Anemia, Hemolytic |
Anti-Infective Agents, Local Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hemoglobinopathies Antifungal Agents Sickle Cell Anemia Hemoglobinopathy Anemia, Sickle Cell |
Anti-Infective Agents Antisickling Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Diseases Clotrimazole Hydroxyurea Miconazole Hematologic Agents Anemia Tioconazole |
Anemia, Hemolytic Enzyme Inhibitors Pharmacologic Actions Anemia, Hemolytic, Congenital Anti-Infective Agents, Local Genetic Diseases, Inborn Therapeutic Uses Hemoglobinopathies Antifungal Agents Anemia, Sickle Cell Nucleic Acid Synthesis Inhibitors |