Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload
NCT ID: NCT00560820
Last Updated: 2020-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
11 participants
INTERVENTIONAL
2007-09-30
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Deferasirox
30 mg/kg/day
Deferasirox
30 mg/kg/day
Interventions
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Deferasirox
30 mg/kg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* β-thalassemia patients receiving regular transfusions every 2-5 weeks
* Transfusion history of ≥ 20 units of packed red blood cells
Exclusion Criteria
* ALT greater than 5 x ULN at screening
* Patients with underlying cardiac disease requiring continuous iron chelation therapy
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmeceuticals
Locations
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Novartis Investigative Site
Cagliari, CA, Italy
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Orbassano, , Italy
Countries
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References
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Piga A, Fracchia S, Lai ME, Cappellini MD, Hirschberg R, Habr D, Wegener A, Bouillaud E, Forni GL. Deferasirox effect on renal haemodynamic parameters in patients with transfusion-dependent beta thalassaemia. Br J Haematol. 2015 Mar;168(6):882-90. doi: 10.1111/bjh.13217. Epub 2014 Nov 17.
Related Links
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Results for CICL670A2123 can be found on the Novartis Clinical Trials Results Website
Other Identifiers
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2006-006838-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CICL670A2123
Identifier Type: -
Identifier Source: org_study_id