Hydroxyurea for the Treatment of Patients With Sickle Cell Anemia
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|ClinicalTrials.gov Identifier: NCT00001197|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : February 12, 2018
A total of fifty severely affected patients with homozygous sickle cell disease or other sickling disorders (e.g. B negative or B positive Thalassemia/Sickle) who are greater than 18 years of age will be eligible for treatment. Such patients must be able to tolerate an extensive period without blood transfusion and have relatively well preserved renal and hepatic function (creatinine less than 1.5 mg/dl and normal liver function test with exception of a mild elevation in transaminase). Evidence of severe sickle cell anemia will include recurrent pain crisis, chronic bone oain, evidence of aseptic necrosis with symptoms, and intractable leg ulcer, etc.
On admission to the study, each patient will receive a complete history and physical examination. These data and standard laboratory evaluation, including a test for pregnancy if appropriate, will be adequate to ascertain whether any of the criteria for exclusion are present. Each patient must accept responsibility for for using an effective means of contraception. Patients who are found to be HIV positive will be excluded from the study.
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Anemia||Drug: Hydroxyurea||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Official Title:||Effect of Hydroxyurea on Fetal Hemoglobin Synthesis in Patients With Sickle Cell Anemia|
|Study Start Date :||February 7, 1984|
|Primary Completion Date :||December 21, 2003|
|Study Completion Date :||May 18, 2015|
U.S. FDA Resources
- An increment in fetal hemoglobin production as a result of hydroxyurea.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001197
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Griffin P Rodgers, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|