Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox

February 1, 2016 updated by: Novartis Pharmaceuticals

International Sentinel Site Surveillance of Patients With Transfusional Hemosiderosis Treated With Deferasirox in Actual Practice Setting

This study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Novartis Investigative Site
      • Cairo, Egypt, 11566
        • Novartis Investigative Site
  • Jordan
      • Amman, Jordan, 11195
        • Novartis Investigative Site
  • Spain
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spain
        • Novartis Investigative Site
      • Barcelona, Cataluña, Spain, 08916
        • Novartis Investigative Site
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Novartis Investigative Site
      • London, United Kingdom, N19 5NF
        • Novartis Investigative Site
      • London, United Kingdom, N18 1QX
        • Novartis Investigative Site
    • Birmingham
      • West Midlands, Birmingham, United Kingdom, B4 6NH
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.

Description

Inclusion Criteria:

-Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information.

(the patients are either beginning treatment with deferasirox at the time of enrollment in the sentinel site monitoring or are currently under treatment with deferasirox and have started the treatment under prescription up to twelve months prior to enrollment in the sentinal site monitoring.

Exclusion Criteria:

  • Patients with non-transfusional hemosiderosis
  • Patients treated with deferasirox in an interventional clinical trial

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
deferasirox
Drug: deferasirox
Other Names:
  • ICL670

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Creatinine and liver enzyme levels
Time Frame: 3 years
Observed over 3 years for each patient
3 years
Adverse Drug Reactions
Time Frame: 3 years
Observed over 3 years for each patient
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 12, 2011

First Submitted That Met QC Criteria

July 13, 2011

First Posted (Estimate)

July 14, 2011

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

February 1, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CICL670A2301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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