|
Protocol Number:
84-H-0029
- Title:
Effect of Hydroxyurea on Fetal Hemoglobin Synthesis in Patients with Sickle Cell Anemia
- Number:
84-H-0029
- Summary:
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.
- Sponsoring Institute:
-
National Heart, Lung and Blood Institute (NHLBI)
- Recruitment Detail
- Type:
No longer recruiting/follow-up only
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
Children
- Eligibility Criteria:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Special Instructions:
Currently Not Provided
- Keyword(s):
-
Gene Expression
-
Gene Therapy
- Recruitment Keyword(s):
-
Sickle Cell Anemia
- Condition(s):
-
Sickle Cell Anemia
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Interventions:
-
Drug: Hydroxyurea
- Supporting Site:
-
National Heart, Lung and Blood Institute
- Contact(s):
-
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
- Citation(s):
-
Hematologic responses of patients with sickle cell disease to treatment with hydroxyurea
-
Hydroxyurea increases fetal hemoglobin in cultured erythroid cells derived from normal individuals and patients with sickle cell anemia and beta-thalassemia
-
Erythropoietin augments the fetal hemoglobin response to hydroxyurea in sickle cell patients
If you have:
Search The Studies | Help | Questions | Clinical Center Home | NIH Home
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 05/05/2009
|
|