Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00432627

Enrollment

Registered

2007-02-08

Start date

2006-12-31

Completion date

2010-08-31

Last updated

2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

Hepatic impairment, adults, deferasirox

Brief summary

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

Interventions

DRUGDeferasirox

one dose of 20 mg/kg/day

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of deferasirox and its metabolites	at FPFV and at LPLV

Secondary

Measure	Time frame
Safety and tolerability of deferasirox assessed by adverse events	at FPFV and at LPLV

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026