Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: Deferasirox

• Registration Number: NCT00432627
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-02-07
• Study First Submitted QC: 2007-02-07
• Study First Posted: 2007-02-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2016-04
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Deferasirox	Controlled group
Mild hepatic impaired	Deferasirox	-
Severe hepatic impaired	Deferasirox	-
Moderate hepatic impaired	Deferasirox	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of deferasirox and its metabolites	at FPFV and at LPLV

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of deferasirox assessed by adverse events	at FPFV and at LPLV

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Kiel, Germany