Status:
COMPLETED
Use of Hydroxyurea and Magnesium Pidolate for Treatment of Sickle Cell Disease
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Anemia, Sickle Cell
Eligibility:
All Genders
3-15 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to estimate the MTD of Mg pidolate in combination with HU in patients with sickle cell disease who have been on a therapeutic dose (15-30 mg/kg/day) of HU for at least 6 m...
Detailed Description
This is a Phase I clinical trial evaluating the combination of hydroxyurea and magnesium pidolate for patients with sickle cell disease with either hemoglobin SS disease or hemoglobin S beta thalassem...
Eligibility Criteria
Inclusion
- Age \> 3 years and \< 15 years at the time of study enrollment
- Diagnosis of Hb SS or Hb S beta thalassemia
- Hydroxyurea treatment for at least 6 months prior to study entry at dose of 15 - 30 mg/kg/day
- Compliance with taking HU treatment of at least 70 % for 6 months prior to study entry
Exclusion
- Red blood cell transfusion within the last 3 months resulting in a level of Hb A of 10% or more
- Pregnancy or unwillingness to use effective birth control in sexually active subjects (females who state that they are sexually active)
- Renal dysfunction defined by a serum creatinine greater than 1.5 times the upper limit of normal for age
- Liver dysfunction defined by an ALT greater than twice the upper limit of normal for age
- Concomitant usage of an "antisickling" agent other than hydroxyurea
- Current use of Mg containing drugs
- Iron deficiency, defined by serum ferritin ≤ 10 ng/ml
- Concomitant chronic illness other than sickle cell anemia
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00143572
Start Date
November 1 2004
End Date
January 1 2008
Last Update
April 26 2017
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105