NCT00379483

Brief Summary

A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload. The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
11 months until next milestone

First Posted

Study publicly available on registry

September 22, 2006

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

October 14, 2005

Last Update Submit

March 18, 2015

Conditions

Transfusional Iron Overload

Keywords

Transfusional iron overloadDeferasirox

Outcome Measures

Primary Outcomes (1)

  • Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment

    at 3, 4, 5 years

Secondary Outcomes (1)

  • Change in liver iron content measured by SQUID, at 3, 4, and 5 years

    at 3, 4, 5 years

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Deferasirox

Interventions

DeferasiroxDRUG
Also known as: ICL670
Arm 1

Eligibility Criteria

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

You may qualify if:

  • Patients with transfusional iron overload who have successfully completed the one year chelation treatment in the deferasirox trial or the food-effect sub-study and who were considered by the investigator eligible to continue chelation therapy with deferasirox

You may not qualify if:

  • Pregnant or breast feeding patients
  • Patients being considered by the investigator potentially unreliable and/or a history of non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Cagliari, Italy

Location

Novartis Investigative Site

Genova, Italy

Location

Novartis Investigative Site

Milan, Italy

Location

Novartis Investigative Site

Torino, Italy

Location

MeSH Terms

Interventions

Deferasirox

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

September 22, 2006

Study Start

July 1, 2002

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

IT(4)