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Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions Clinical research trials and Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions. Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions  Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions
Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions
For Condition: beta-Thalassemia
Status: Recruiting
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: The purpose of this study is to deterimine if the new orally active iron chelator, ICL670, is as effective and 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 to live 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: 2 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Beta-thalassemia patients already treated with or suitable for treatment with deferoxamine 20 to 40 mg/kg/day - Liver iron content greater than 2 mg iron/g dw as measured by liver biopsy - Need for regular transfusions 8 or more times per year Exclusion Criteria: - Non-transfusional iron overload or transfusion-dependent anemias other than beta-thalassemia. - 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 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 additive 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. - Inability to undergo a liver biopsy. - Patients that would need a dose of ICL670 less than 125 mg per day.
Total Enrollment: 500
Location and Contact Information:
Children's Hospital Boston *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Jennifer Braunstein 617-355-2457
Children's Memorial Hospital *Recruiting*
Chicago, Illinois, 60614-3394
United States
Recruiting Dena Haddad 773-880-3533
Stanford Hospital *Recruiting*
Stanford, California, 94305-5208
United States
Recruiting Keniki McNeil 650-724-7123
Children's Hospital Oakland *Recruiting*
Oakland, California, 94609
United States
Recruiting Jacqueline Madden 510-428-3885
Weill Medical College of Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Victor Apostolou 212-746-3942
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Marie Martin 215-590-2197
Children's Hospital of Los Angeles *Not yet recruiting*
Los Angeles, California, 90027-6062
United States
Not yet recruiting Susan Carson 323-669-4132
Additional Information:
Study ID Numbers: CICL670A0107;
Study Start Date: May 2003
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061750
Other Beta-Thalassemia Studies:
1. Iron Balance Study of DFO and GT56-252 in Patients with Transfusional Iron Overload Secondary to Beta-Thalassemia
2. Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias
3. Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions
4. Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN)
5. Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia
Related Studies:
Other beta-Thalassemia Clinical Trials
Other California Clinical Trials
Other Stanford Clinical Trials
Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions
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