Hydroxyurea and Magnesium Pidolate to Treat People With Hemoglobin Sickle Cell Disease

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hemoglobin SC Disease

In brief

Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. Hemoglobin SCD (HbSC) is a form of SCD that is characterized by dense red blood cells. The purpose of this study is to evaluate the safety and effectiveness of hydroxyurea and magnesium pidolate, alone and combined, at reducing red blood cell density and the frequency of pain episodes in people with HbSC.

Key facts

Study ID

NCT00532883

Run by

St. Jude Children's Research Hospital

People needed

44

Starts

2007-01-01

Expected to finish

2009-08-01

Last updated by the study team

2013-01-18

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of HbSC disease
• Hemoglobin level between 8 and 12.5 g/dL
• At least one vaso-occlusive event (e.g., pain, acute chest syndrome) in the 12 months prior to study entry. An episode of pain is defined as the occurrence of pain in the extremities, back, abdomen, chest, or head that lasts at least 2 hours; requires a visit to a hospital, emergency room, clinic, or provider's office; and is not explained except by SCD. Acute chest syndrome is defined as a new pulmonary infiltrate on a chest x-ray associated with a fever (greater than 38.5° C), tachypnea, wheezing, cough, or chest pain.
• Regular compliance with comprehensive care
• In a steady disease state and not experiencing an acute complication of SCD (i.e., no hospitalization, pain event, or episode of acute chest syndrome within the 1 month prior to study entry)

You may not qualify if…

• Previous transfusion with remaining hemoglobin A greater than 10%
• Previous treatment with hydroxyurea within the last 3 months
• Previous treatment with magnesium within the 3 months prior to study entry (including vitamins containing magnesium)
• Poor compliance with previous treatment regimens
• Liver dysfunction (SGPT greater than twice the upper limit of normal) within the 1 month prior to study entry
• Kidney dysfunction (creatinine greater than or equal to 1.0 mg/dL for participants less than 18 years of age; greater than or equal to 1.2 mg/dL for participants 18 years of age or older) within the 1 month prior to study entry
• Pregnant
• Ten or more hospital admissions for pain in the 12 months prior to study entry
• Daily use of narcotics
• Treatment with any investigational drug in the 3 months prior to study entry
• Less than 3% red blood cells with density greater than 41 g/dL (as measured by the ADVIA 120 system)
• Positive HIV test
• Other long-term illness or disorder other than SCD that could adversely affect performance in the study (e.g., tuberculosis)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Children's Hospital and Research Center — Oakland, California, United States
• University of California Davis — Sacramento, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of Miami — Miami, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• University of Louisville — Louisville, Kentucky, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Saint Christopher's Hospital — Philadelphia, Pennsylvania, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Children's Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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