NCT00432627

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 9, 2020

Status Verified

April 1, 2016

Enrollment Period

3.7 years

First QC Date

February 7, 2007

Last Update Submit

December 6, 2020

Conditions

Hepatic Impairment

Keywords

Hepatic impairmentadultsdeferasirox

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of deferasirox and its metabolites

    at FPFV and at LPLV

Secondary Outcomes (1)

  • Safety and tolerability of deferasirox assessed by adverse events

    at FPFV and at LPLV

Study Arms (4)

Mild hepatic impaired

EXPERIMENTAL
Drug: Deferasirox

Moderate hepatic impaired

EXPERIMENTAL
Drug: Deferasirox

Severe hepatic impaired

EXPERIMENTAL
Drug: Deferasirox

Healthy volunteers

EXPERIMENTAL

Controlled group

Drug: Deferasirox

Interventions

DeferasiroxDRUG

one dose of 20 mg/kg/day

Also known as: ICL670
Healthy volunteersMild hepatic impairedModerate hepatic impairedSevere hepatic impaired

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physical signs consistent with a clinical diagnosis of liver cirrhosis
  • Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
  • Otherwise considered healthy
  • In good health.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Kiel, Germany

Location

Related Links

MeSH Terms

Interventions

Deferasirox

Intervention Hierarchy (Ancestors)

BenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmeceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2007

First Posted

February 8, 2007

Study Start

December 1, 2006

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 9, 2020

Record last verified: 2016-04

Locations

DE(1)