- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01394029
Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox
International Sentinel Site Surveillance of Patients With Transfusional Hemosiderosis Treated With Deferasirox in Actual Practice Setting
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt
- Novartis Investigative Site
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Cairo, Egypt, 11566
- Novartis Investigative Site
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Amman, Jordan, 11195
- Novartis Investigative Site
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Asturias
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Oviedo, Asturias, Spain, 33006
- Novartis Investigative Site
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Cataluña
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Barcelona, Cataluña, Spain
- Novartis Investigative Site
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Barcelona, Cataluña, Spain, 08916
- Novartis Investigative Site
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London, United Kingdom, SE5 9RS
- Novartis Investigative Site
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London, United Kingdom, N19 5NF
- Novartis Investigative Site
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London, United Kingdom, N18 1QX
- Novartis Investigative Site
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Birmingham
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West Midlands, Birmingham, United Kingdom, B4 6NH
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
-Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.
(the patients are either beginning treatment with deferasirox at the time of enrollment in the sentinel site monitoring or are currently under treatment with deferasirox and have started the treatment under prescription up to twelve months prior to enrollment in the sentinal site monitoring.
Exclusion Criteria:
- Patients with non-transfusional hemosiderosis
- Patients treated with deferasirox in an interventional clinical trial
Other protocol-defined inclusion/exclusion criteria may apply.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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deferasirox
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Serum Creatinine and liver enzyme levels
Time Frame: 3 years
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Observed over 3 years for each patient
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3 years
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Adverse Drug Reactions
Time Frame: 3 years
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Observed over 3 years for each patient
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3 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CICL670A2301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Transfusional Hemosiderosis
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Novartis PharmaceuticalsCompletedTransfusional Hemosiderosis | Transfusional Iron OverloadTaiwan, Turkey, Egypt, United Kingdom, Thailand, Canada, China, Italy, Cyprus, Lebanon, United Arab Emirates
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ShireWithdrawnMetabolic Diseases | Iron Metabolism Disorders | Iron Overload | Beta-thalassemia | Transfusional Hemosiderosis | Transfusional Iron Overload | Iron Chelation
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Novartis PharmaceuticalsCompletedTransfusional HemosiderosisUnited States
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Novartis PharmaceuticalsCompletedTransfusional Hemosiderosis | Chronic AnemiaJapan, Turkey, Spain, Poland, Singapore
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Novartis PharmaceuticalsCompletedTransfusional Iron OverloadItaly
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ApoPharmaCompletedTransfusional Iron OverloadEgypt, Cyprus, Oman, Saudi Arabia, Turkey
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Sun Yat-sen UniversityUnknownIdiopathic Pulmonary Hemosiderosis
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Ramsay Générale de SantéEuropean Clinical Trial Experts NetworkNot yet recruitingDialysis | Iron Deposition | Iatrogenic HemosiderosisFrance
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingIdiopathic Pulmonary Hemosiderosis | LeflunomideChina
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Novartis PharmaceuticalsCompletedTransfusional Iron OverloadUnited States, Greece, Italy
Clinical Trials on deferasirox
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Novartis PharmaceuticalsCompletedTransfusion-dependent AnemiaEgypt, Hungary, Turkey, United States, Bulgaria, Italy, Belgium, Russian Federation, Philippines, France, Malaysia, India, Oman, Panama, Lebanon, Thailand, Tunisia
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Novartis PharmaceuticalsCompletedNon-transfusion-dependent Thalassemia | Transfusion-dependent ThalassemiaEgypt, Turkey, Thailand, Lebanon, Morocco, Saudi Arabia, Vietnam
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DisperSol Technologies, LLCCompletedThalassemia MajorThailand, United States
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Novartis PharmaceuticalsWithdrawnThalassemia (Transfusion Delendent)
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Assistance Publique - Hôpitaux de ParisAssociation pour l'Etude des Fonctions Digestives (AEFD)UnknownPorphyria Cutanea TardaFrance
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Novartis PharmaceuticalsCompletedLow and Int 1-risk Myelodysplastic SyndromeGermany, Canada, Korea, Republic of, Sweden, Spain, China, Argentina, Italy, United Kingdom, Algeria
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NovartisCompletedBeta-Thalassemia | HemosiderosisEgypt, Lebanon, Oman, Saudi Arabia, Syrian Arab Republic
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Novartis PharmaceuticalsCompletedNon-transfusion Dependent ThalassemiaThailand, Turkey, Italy, Greece, China, United Kingdom, Lebanon, Tunisia
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City of Hope Medical CenterTerminatedPrimary Myelofibrosis | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Iron Overload | Chronic Myelomonocytic Leukemia | Recurrent Adult Acute Myeloid Leukemia | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell... and other conditionsUnited States
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Crolll GmbhUniversity of Magdeburg; Estimate, GmbHCompletedNon-alcoholic Steatohepatitis | Increased Iron Storage / Disturbed DistributionGermany