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Safety of ICL670 vs. deferoxamine in sickle cell disease patients with iron overload due to blood transfusions Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Safety of ICL670 vs. deferoxamine in sickle cell disease patients with iron overload due to blood transfusions conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Safety of ICL670 vs. deferoxamine in sickle cell disease patients with iron overload due to blood transfusions Clinical research trials and Safety of ICL670 vs. deferoxamine in sickle cell disease patients with iron overload due to blood transfusions health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Safety of ICL670 vs. deferoxamine in sickle cell disease patients with iron overload due to blood transfusions. Safety of ICL670 vs. deferoxamine in sickle cell disease patients with iron overload due to blood transfusions Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety of ICL670 vs. deferoxamine in sickle cell disease patients with iron overload due to blood transfusions clinical trial. Test subjects typically receive the most expert healthcare available for their Safety of ICL670 vs. deferoxamine in sickle cell disease patients with iron overload due to blood transfusions condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety of ICL670 vs. deferoxamine in sickle cell disease patients with iron overload due to blood transfusions  Safety of ICL670 vs. deferoxamine in sickle cell disease patients with iron overload due to blood transfusions
Safety of ICL670 vs. deferoxamine in sickle cell disease patients with iron overload due to blood transfusions
For Condition: Sickle Cell Disease
Status: Recruiting
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: The purpose of this study is to determine if the new orally active iron chelator, ICL670, is as safe as deferoxamine in preventing accumulation of iron in the body while a patient is undergoing repeated blood transfusions.
Details: Patients who require repeated blood transfusions accumulate iron in the body as blood cells contain iron and there is no natural body mechanism to eliminate it. After a while the iron levels get high enough to be toxic to the body. The current therapy of choice is deferoxamine which does a good job of removing excess iron, but is difficult to administer. Deferoxamine requires subcutaneous (under the skin) infusions over 4 to 8 hours nightly 3 to 7 nights per week. In addition to the need to wear an infusion pump nightly, adverse reactions around the site of the injection are frequent.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Sickle cell disease patients already treated with or suitable for treatment with deferoxamine 20 to 40 mg/kg/day - Serum ferritin greater than 1000 mg/ml - Liver iron content greater than 2 mg iron/g dw assessed by means of SQUID for patients who receive simple transfusions and greater than 5 mg iron/ g dw for patients who receive exchange transfusions - Regular transfusion aimed at maintaining % Hb A above 50% Exclusion Criteria: - Chronic anemias other than sickle cell disease - Documented toxicity to deferoxamine - Elevated liver enzymes in the year preceeding enrollment - Active hepatitis B or hepatitis C - HIV seropositivity - Elevated serum creatinine or significant proteinuria - History of nephrotic syndrome - Uncontrolled systemic hypertension - Fever and other signs/symptoms of infection within 10 days prior to the start of the study - Presence of clinically relevant cataract or previous history of clinically relevant ocular toxicity related to iron chelation - Second or third degree AV block, clinically relevant Q-T interval prolongation, or patients requiring digoxin or other drugs that prolong the Q-T interval - Diseases (cardiovascular, renal, hepatic, etc.) that would prevent the patient from undergoing any of the treatment options - Psychiatric or addictive disorders that would prevent the patient from giving informed consent - History of drug or alcohol abuse within the 12 months prior to the study - Pregnant or breast feeding patients - Patients treated with systemic investigational drugs within 4 weeks or topical investigational drugs within 7 days before the start of the study - Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug, such as gastrointestinal disease or major surgery, renal disease, difficulty voiding or urinary obstruction, or impaired pancreatic function - Non-compliant or unreliable patients - Patients unable to undergo any study procedures such as the hearing or eye tests, or the liver echocardiography
Total Enrollment: 90
Location and Contact Information:
Liberty Hematology Oncology Center *Not yet recruiting*
Columbia, South Carolina, 29203
United States
Not yet recruiting Norie Yasuda 803-256-0254
Wake Forest University School of Medicine *Not yet recruiting*
Winston Salem, North Carolina,
United States
Not yet recruiting Cynthia Harris
Georgia Comprehensive Sickle cell Center, Grady Hospital *Not yet recruiting*
Atlanta, Georgia, 30335
United States
Not yet recruiting Eldrida Carter-Randall
Sickle Cell Center, Montefiore Hospital *Not yet recruiting*
Bronx, New York, 10467
United States
Not yet recruiting Bernadette Eaton 718-920-7374
Santee Hematology/Oncology *Recruiting*
Sumter, South Carolina, 29150
United States
Recruiting Wei Chang
Palmetto Health Clinical Trials *Not yet recruiting*
Columbia, South Carolina, 29203
United States
Not yet recruiting Betty Johnson
Children's Hospital & Research Center *Recruiting*
Oakland, California, 94609
United States
Recruiting Jacqueline Madden
U. of S. Alabama Medical Center *Not yet recruiting*
Mobile, Alabama, 36604
United States
Not yet recruiting Felicia Wilson
Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Pam Pemberton
Children's Hospital Los Angeles *Not yet recruiting*
Los Angeles, California, 90027
United States
Not yet recruiting Susan Carson
Children's Hospital Medical Center *Not yet recruiting*
Cincinnati, Ohio, 45229
United States
Not yet recruiting Patrick Kelly
NY Methodist Hospital *Not yet recruiting*
Brooklyn, New York, 11215
United States
Not yet recruiting Rita Bellvue
Howard University Hospital *Recruiting*
Washington D.C., District of Columbia, 20059
United States
Recruiting Catherine Nwokolo 202-806-7265
U. Of Rochester Medical Center *Not yet recruiting*
Rochester, New York, 14642
United States
Not yet recruiting Camille Abboud 716-275-2224
Baylor College of Medicine *Not yet recruiting*
Houston, Texas, 77030
United States
Not yet recruiting Myra Dobbs
Adult Sickle Cell Clinic, Medical College of Georgia *Recruiting*
Augusta, Georgia, 30912
United States
Recruiting Leigh Wells
Children's Hospital of the King's Daughter *Not yet recruiting*
Norfolk, Virginia, 23507
United States
Not yet recruiting William Owen
Colorado Sickle Cell Treatment and Research Center *Not yet recruiting*
Denver, Colorado, 80262
United States
Not yet recruiting Shannon Gillette
Boston Medical Center *Not yet recruiting*
Boston, Massachusetts, 02118
United States
Not yet recruiting Adeboye Adewoye
Tulane University Sickle Cell Center *Not yet recruiting*
New Orleans, Louisiana, 70112
United States
Not yet recruiting Maye Jones 504-588-5413
James Cancer Hospital *Not yet recruiting*
Columbus, Ohio, 43210
United States
Not yet recruiting Sara Jefferson 614-293-7894
Additional Information:
Study ID Numbers: CICL670A0109;
Study Start Date: May 2003
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067080
Other Sickle Cell Disease Studies:
1. Safety of ICL670 vs. deferoxamine in sickle cell disease patients with iron overload due to blood transfusions
2. Home Based Massage and Relaxation for Sickle Cell Pain
3. A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia.
4. Atorvastatin Therapy to Improve Endothelial Function in Sickle Cell Disease
5. Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
Related Studies:
Other Sickle Cell Disease Clinical Trials
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Safety of ICL670 vs. deferoxamine in sickle cell disease patients with iron overload due to blood transfusions
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