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Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias Clinical research trials and Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias. Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias clinical trial. Subjects often receive the most expert healthcare possible for their Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias  Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias
Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias
For Condition: beta-Thalassemia,Fanconi Syndrome,Myelodysplastic Syndromes,Anemia, Aplastic,Anemia, Diamond-Blackfan
Status: Completed
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: The purpose of this study is to determine the effects of the oral iron chelator ICL670 on liver iron content after one year of treatment in patients with iron overload from repeated blood transfusions. Beta-thalassemia patients unable to be treated with deferoxamine or patients with rare chronic anemias such as Myelodysplastic Syndrome, Fanconi's Syndrome, Blackfan-Diamond Syndrome, and Pure Red Blood Cell Anemia are eligible for this study. Liver iron content will be measured by liver biopsy at the beginning of the study and after one year of treatment. However, those patients living in the San Francisco/Oakland area may have a SQUID in place of the liver biopsy if the biopsy is not medically possible for them. The SQUID is a non-invasive magnetic means to measure liver iron content.
Details: Patients who require repeated blood transfusions to live accumulate iron in the body as red 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 a week. Skin reactions at the injection site can occur. In addition, as with all drugs, side effects also can occur. Allergic reactions, kidney problems, and eye and hearing probelms are all known to happen with deferoxamine. Beta-thalassemia patients who are not able to take deferoxamine because of side effects are eligible for this study. In addition, this study will also include patients with rare, transfusion dependent anemias such a Myelodysplastic Syndrome, Fanconi's Syndrome, Blackfan-Diamond Syndrome, and Pure Red Blood Cell Anemia. Patients with rare transfusion dependent anemias need not have had a side effect to deferoxamine to be eligible.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 2 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Beta-thalassemia patients with documented non-compliance to deferoxamine, defined as taking less than 50% of prescribed doses in year prior to study, and having a liver iron content at least 14 mg iron/gm dry weight liver tissue - Beta-thalassemia patients unable to take deferoxamine because of documented side effects or contra-indication, or documented poor response despite proper compliance, with liver iron content at least 2 mg iron/gm dry weight liver tissue - Patients with chronic anemias with a liver iron content at least 2 mg/gm dry weight liver tissue. - Beta-thalassemia or other chronic anemia patients having previously taken deferiprone, provided that they stop the deferiprone at least 28 days before the study and have a liver iron content at least 2 mg/gm dry weight liver tissue. - All patients: Regular transfusions indicated by a requirement of at least 8 blood transfusions per year. - Life expectancy of at least one year. Exclusion Criteria: - Beta-thalassemia able to be treated with deferoxamine, Sickle Cell Disease or non-transfusional iron overload - Elevated liver enzymes in the year preceding 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 teh 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. - Patients that would need a dose of ICL670 less than 125 mg per day.
Total Enrollment: 175
Location and Contact Information:
Stanford Hospital
Stanford, California, 94305-5208
United States
Children's Hospital Oakland
Oakland, California, 94609
United States
Weill Medical College of Cornell University
New York City, New York, 10021
United States
Children's Hospital Boston
Boston, Massachusetts, 02115
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4318
United States
Northwest Medical Specialists
Arlington Heights, Illinois, 60004
United States
Additional Information:
Study ID Numbers: CICL670A0108;
Study Start Date: May 2003
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061763
Other Myelodysplastic Syndromes Studies:
1. Thalidomide in Treating Anemia in Patients With Myelodysplastic Syndrome
2. Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
3. Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality
4. Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
5. Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome
Related Studies:
Other Myelodysplastic Syndromes Clinical Trials
Other Illinois Clinical Trials
Other Arlington Heights Clinical Trials
Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias
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