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Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes

Information source: FDA Office of Orphan Products Development
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sickle Cell Anemia

Intervention: clotrimazole (Drug); hydroxyurea (Drug)

Phase: N/A

Status: Completed

Sponsored by: Children's Hosptial of Boston

Official(s) and/or principal investigator(s):
Carlo Brugnara, Study Chair, Affiliation: Children's Hospital Boston


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.

Clinical Details

Study design: Primary Purpose: Treatment

Detailed description: PROTOCOL OUTLINE: Patients receive oral hydroxyurea either once or twice daily plus oral clotrimazole twice daily after meals for 6 months. Patients are assessed at 3 and 6 months during treatment. Completion date provided represents the completion date of the grant per OOPD records


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- -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

- Patient Characteristics-- Performance status: Karnofsky 70-100%

Hematopoietic: WBC within normal limits Platelet count within normal limits Hepatic: No history of chronic liver disease Bilirubin less than 2 times normal SGOT and SGPT less than 2. 5 times normal No severe hepatic damage Renal: Creatinine within normal limits No severe renal damage Neurologic: No severe neurologic impairment No recent or progressive neurologic impairment Other: Not pregnant Fertile patients must use effective contraception No allergies to hydroxyurea or clotrimazole

Locations and Contacts

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Children's Hospital - Boston, Boston, Massachusetts 02115, United States

Additional Information

Starting date: April 1997
Last updated: March 24, 2015

Page last updated: August 23, 2015

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