Study Stopped
Enrollment has been terminated due to a slow rate of enrollment.
Hydroxyurea and Magnesium Pidolate to Treat People With Hemoglobin Sickle Cell Disease
Effectiveness of Hydroxyurea and Magnesium Pidolate Alone and in Combination in Hemoglobin SC Disease: A Phase II Trial
2 other identifiers
interventional
44
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2007
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 20, 2007
CompletedFirst Posted
Study publicly available on registry
September 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
May 11, 2010
CompletedJanuary 18, 2013
January 1, 2010
2.2 years
September 20, 2007
April 1, 2010
January 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Distribution of the Density of Hemoglobin SC Red Cells
An individuals' percentage of red blood cells with density greater than 41 g/dL as measured by Advia.
measured 2 months after initiation of treatment
Study Arms (4)
Placebo Pills and Placebo Liquid
PLACEBO COMPARATORHydroxyurea Pills and Placebo Liquid
ACTIVE COMPARATORPlacebo Pills and Magnesium Pidolate Liquid
ACTIVE COMPARATORHydroxyurea Pills and Magnesium Pidolate Liquid
ACTIVE COMPARATORInterventions
HU capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months)
HU/Placebo capsules (20 mg/kg/day for 11 months) Mg liquid (0.6 mEq/kg/day for 11 months)
HU/Placebo capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months)
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Children's Hospital and Research Center
Oakland, California, 94609-1809, United States
University of California Davis
Sacramento, California, 95817, United States
University of Colorado
Aurora, Colorado, 80045, United States
University of Miami
Miami, Florida, 33136, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342-1600, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Children's Hospital Boston
Boston, Massachusetts, 02118, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Montefiore Medical Center
The Bronx, New York, 10463, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Saint Christopher's Hospital
Philadelphia, Pennsylvania, 19134-1095, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19444, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Children's Medical Center
Dallas, Texas, 75235, United States
Related Publications (1)
Wang W, Brugnara C, Snyder C, Wynn L, Rogers Z, Kalinyak K, Brown C, Qureshi A, Bigelow C, Neumayr L, Smith-Whitley K, Chui DH, Delahunty M, Woolson R, Steinberg M, Telen M, Kesler K. The effects of hydroxycarbamide and magnesium on haemoglobin SC disease: results of the multi-centre CHAMPS trial. Br J Haematol. 2011 Mar;152(6):771-6. doi: 10.1111/j.1365-2141.2010.08523.x. Epub 2011 Jan 31.
PMID: 21275961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was stopped early due to slow enrollment. It should therefore be viewed as a pilot study.
Results Point of Contact
- Title
- Harvey Luksenburg
- Organization
- NHLBI
Study Officials
- PRINCIPAL INVESTIGATOR
Winfred C. Wang, MD
St. Jude Children's Research Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2007
First Posted
September 21, 2007
Study Start
January 1, 2007
Primary Completion
March 1, 2009
Study Completion
August 1, 2009
Last Updated
January 18, 2013
Results First Posted
May 11, 2010
Record last verified: 2010-01