Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
NCT ID: NCT00432627
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
24 participants
INTERVENTIONAL
2006-12-31
2010-08-31
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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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mild hepatic impaired
Deferasirox
one dose of 20 mg/kg/day
Moderate hepatic impaired
Deferasirox
one dose of 20 mg/kg/day
Severe hepatic impaired
Deferasirox
one dose of 20 mg/kg/day
Healthy volunteers
Controlled group
Deferasirox
one dose of 20 mg/kg/day
Interventions
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Deferasirox
one dose of 20 mg/kg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
* Otherwise considered healthy
• In good health.
Exclusion Criteria
* Clinical evidence of severe ascites
* History of surgical portosystemic shunt
* Any evidence of progressive liver disease within the last 4 weeks
* Clinical evidence of liver disease or liver injury
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
* Use of any prescription medication within 1 month prior to dosing
18 Years
75 Years
ALL
Yes
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 Pharmeceuticals
Locations
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Novartis Investigative Site
Kiel, , Germany
Countries
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Related Links
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Results can be found for CICL670A2125 on the Novartis Clinical Trial Results Website
Other Identifiers
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CICL670A2125
Identifier Type: -
Identifier Source: org_study_id