Back to resultsImpact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
Primary Purpose
Hepatic Impairment
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Deferasirox
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment focused on measuring Hepatic impairment, adults, deferasirox
Eligibility Criteria
Inclusion criteria for those with hepatic impairment:
- Physical signs consistent with a clinical diagnosis of liver cirrhosis
- Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
- Otherwise considered healthy
Inclusion criteria for healthy volunteers:
• In good health.
Exclusion criteria for those with hepatic impairment:
- Clinically significant abnormal findings other than hepatic impairment
- Clinical evidence of severe ascites
- History of surgical portosystemic shunt
- Any evidence of progressive liver disease within the last 4 weeks
Exclusion criteria for healthy controls:
- 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
Other protocol defined inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Mild hepatic impaired
Moderate hepatic impaired
Severe hepatic impaired
Healthy volunteers
Arm Description
Controlled group
Outcomes
Primary Outcome Measures
Pharmacokinetics of deferasirox and its metabolites
Secondary Outcome Measures
Safety and tolerability of deferasirox assessed by adverse events
Full Information
NCT ID
NCT00432627
First Posted
February 7, 2007
Last Updated
December 6, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00432627
Brief Title
Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
Official Title
An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of 20 mg/kg Oral Deferasirox in Patients With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
Keywords
Hepatic impairment, adults, deferasirox
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild hepatic impaired
Arm Type
Experimental
Arm Title
Moderate hepatic impaired
Arm Type
Experimental
Arm Title
Severe hepatic impaired
Arm Type
Experimental
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Controlled group
Intervention Type
Drug
Intervention Name(s)
Deferasirox
Other Intervention Name(s)
ICL670
Intervention Description
one dose of 20 mg/kg/day
Primary Outcome Measure Information:
Title
Pharmacokinetics of deferasirox and its metabolites
Time Frame
at FPFV and at LPLV
Secondary Outcome Measure Information:
Title
Safety and tolerability of deferasirox assessed by adverse events
Time Frame
at FPFV and at LPLV
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for those with hepatic impairment:
Physical signs consistent with a clinical diagnosis of liver cirrhosis
Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
Otherwise considered healthy
Inclusion criteria for healthy volunteers:
• In good health.
Exclusion criteria for those with hepatic impairment:
Clinically significant abnormal findings other than hepatic impairment
Clinical evidence of severe ascites
History of surgical portosystemic shunt
Any evidence of progressive liver disease within the last 4 weeks
Exclusion criteria for healthy controls:
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
Other protocol defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmeceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Kiel
Country
Germany
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4382
Description
Results can be found for CICL670A2125 on the Novartis Clinical Trial Results Website
Learn more about this trial
Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
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