ENTRUST, a 5 Year Surveillance of Children Aged 2 to <6 Years With Transfusional Iron Overload Treated With Deferasirox

NCT ID: NCT00466063

Last Updated: 2015-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This registry will evaluate long-term safety and efficacy of deferasirox in children with transfusional iron overload.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Iron overload children deferasirox Transfusion-dependent anemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICL670

ICL670

Deferasirox

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Deferasirox

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* History of transfusion-dependent anemia.
* History of iron overload

Exclusion Criteria

* Patients with non-transfusional hemosiderosis.
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of South Alabama Medical Center

Mobile, Alabama, United States

Site Status

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Children's Hospital Oakland

Oakland, California, United States

Site Status

Children's Hospital of Orange County

Orange, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

MD Anderson Cancer Center - Orlando

Orlando, Florida, United States

Site Status

St. Joseph's Children's Hospital of Tampa

Tampa, Florida, United States

Site Status

Children's Memorial Hospital

Chicago, Illinois, United States

Site Status

Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

St. Joseph's Children's Hospital

Paterson, New Jersey, United States

Site Status

The Brooklyn Hospital Center

Brooklyn, New York, United States

Site Status

Schneider Children's Hospital

New York, New York, United States

Site Status

SUNY - Upstate Medical University

Syracuse, New York, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

Akron Children's Hospital

Akron, Ohio, United States

Site Status

Children's Medical Center

Dayton, Ohio, United States

Site Status

Oklahoma State University Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Penn State University / Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

St. Jude Children's Research Hospital Memphis

Memphis, Tennessee, United States

Site Status

Cook's Children's Medical Center

Fort Worth, Texas, United States

Site Status

Texas Children's Hospital

Houston, Texas, United States

Site Status

Children's Hospital of the King's Daughters

Norfolk, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CICL670A2411

Identifier Type: -

Identifier Source: org_study_id