NCT00000623

Brief Summary

The purpose of the TCRN is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers in North America. The emphasis will be on clinical trials that help identify optimal therapy. Therapeutic trials may involve investigational drugs, drugs already approved but not currently used, and drugs currently used.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2000

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

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

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2000

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

March 4, 2014

Status Verified

July 1, 2006

First QC Date

October 27, 1999

Last Update Submit

March 3, 2014

Conditions

Anemia, Cooley'sBeta-ThalassemiaHematologic DiseasesThalassemiaOsteoporosisIron OverloadHypertension, Pulmonary

Keywords

chelatorirontransfusionanemiathalassemia

Outcome Measures

Primary Outcomes (1)

  • Vary by protocol

Interventions

DeferoxamineDRUG
DeferiproneDRUG
ArginineDRUG
SildenafilDRUG
DecitabineDRUG

Eligibility Criteria

Age1 Year - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Please refer to specific studies for eligibility criteria.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Children's Hospital Oakland

Oakland, California, 94609, United States

Location

Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

  • Cunningham MJ, Macklin EA, Neufeld EJ, Cohen AR; Thalassemia Clinical Research Network. Complications of beta-thalassemia major in North America. Blood. 2004 Jul 1;104(1):34-9. doi: 10.1182/blood-2003-09-3167. Epub 2004 Feb 26.

    PMID: 14988152BACKGROUND

MeSH Terms

Conditions

beta-ThalassemiaHematologic DiseasesThalassemiaOsteoporosisIron OverloadHypertension, PulmonaryAnemia

Interventions

DeferoxamineDeferiproneArginineSildenafil CitrateDecitabine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesIron Metabolism DisordersLung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic AcidsHydroxylaminesAminesOrganic ChemicalsHydroxy AcidsCarboxylic AcidsPyridonesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, EssentialSulfonamidesAmidesSulfonesSulfur CompoundsPiperazinesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAzacitidineAza CompoundsCytidinePyrimidine NucleosidesPyrimidinesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Alan R. Cohen, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

  • Patricia J. Giardina, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • Ellis J. Neufeld, MD, PhD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

  • Nancy F. Olivieri, MD

    Toronto General Hospital

    PRINCIPAL INVESTIGATOR

  • Elliott P. Vichinsky, MD

    UCSF Benioff Children's Hospital Oakland

    PRINCIPAL INVESTIGATOR

  • Sonja McKinlay, PhD

    New England Research Institutes, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

July 1, 2000

Study Completion

July 1, 2006

Last Updated

March 4, 2014

Record last verified: 2006-07

Locations

US(4)CA(1)