Evaluation of the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration of ICL670 Relative to Deferoxamine(DFO).
NCT ID: NCT01090323
Last Updated: 2011-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
185 participants
INTERVENTIONAL
2004-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ICL670
ICL670
Daily doses of ICL670 were taken orally 30 minutes before breakfast. The doses range from 5-40 mg/kg and were determined based on the patient's trend in serum ferritin over time during the core study (0109) and on the frequency of blood transfusions the patient received. The treatment duration was up to 4 years.
Interventions
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ICL670
Daily doses of ICL670 were taken orally 30 minutes before breakfast. The doses range from 5-40 mg/kg and were determined based on the patient's trend in serum ferritin over time during the core study (0109) and on the frequency of blood transfusions the patient received. The treatment duration was up to 4 years.
Eligibility Criteria
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Inclusion Criteria
* Completion of the core \[Study 0109\]
* Serum ferritin greater than or equal to 500 µg/L
* Ability to comply with all study-related procedures, medications, and evaluations
* Sexually active post-menarche female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.
* Written informed consent and assent by the patient and or their parents or legal guardian.
Exclusion Criteria
* History of non-compliance to medical regimens and patients who are considered potentially unreliable and/or not cooperative
* Serum creatinine above the age-appropriate upper limit of normal within one week prior to entry
* Patients with ALT ≥ 500 U/L within one week prior to entry
* Evidence of chelation-related cataracts or hearing loss within 4 weeks prior to baseline
* Pregnancy (as indicated by serum β-HCG pregnancy test for all female patients with the potential to become pregnant) and patients who are breastfeeding
* Patients treated with systemic investigational drug within 4 weeks prior to or with topical investigational drug within 7 days prior to the baseline visit
2 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of South Alabama College of Medicine
Mobile, Alabama, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital & Research Center at Oakland
Oakland, California, United States
University of Colorado Health Science Center
Denver, Colorado, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
St Joseph Children's Hospital of Tampa
Tampa, Florida, United States
Grady Hospital, Georgia Comprehensive Sickle Cell Center
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
LSUHSC Dept of Pediatrics
Shreveport, Louisiana, United States
Children's Hospital Boston
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
New York Methodist Hospital
Brooklyn, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Children's Hospital Medical Center
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Yasin
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Palmetto Health Richland
Columbia, South Carolina, United States
Santee Hematology/Oncology
Sumter, South Carolina, United States
St. Jude's Children Research Hospital
Memphis, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
Novartis Investigative Site
Toronto, , Canada
Novartis Investigative Site
Créteil, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Catania, , Italy
Novartis Investigative Site
Genova, , Italy
Novartis Investigative Site
Milan, , Italy
Novartis Investigative Site
Roma, , Italy
Novartis Investigative Site
London, , United Kingdom
Countries
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Other Identifiers
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EudraCT no. 2004-000597-31
Identifier Type: REGISTRY
Identifier Source: secondary_id
CICL670A0109E1
Identifier Type: -
Identifier Source: org_study_id
NCT00171197
Identifier Type: -
Identifier Source: nct_alias
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