ICON1: Treatment Decisions and Outcomes in Pediatric Refractory ITP
NCT ID: NCT01971684
Last Updated: 2020-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
120 participants
OBSERVATIONAL
2013-08-31
2017-04-30
Brief Summary
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Detailed Description
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Primary Objectives:
1. To model factors that determine physician treatment decisions in selecting specific second line agents in pediatric ITP.
2. To assess patient reported outcomes with relation to specific second line pediatric ITP therapies.
3. To determine the comparative effectiveness of second line ITP treatments in terms of bleeding and platelet counts.
Secondary Objectives:
1. To describe phenotypic variation among patients with refractory ITP;
2. To assess side effects and complications related to specific treatments for refractory ITP;
3. To describe monitoring and follow up practices among pediatric hematologists with each second line agent;
4. To weight factors that physicians use when deciding to treat pediatric ITP patients with second line agents;
5. To determine whether physician perception of patient quality of life correlates with patient derived quality of life measures;
6. To measure the correlation between the ITP Bleeding Scale and the Bleeding Assessment Tool in refractory pediatric ITP patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Refractory Pediatric ITP Patients
Pediatric ITP patients, ages 1-18, starting a new second line ITP therapy, defined as not IVIG, steroids, anti-D, or aminocaproic acid.
Second Line ITP agents
The treating physicians will select the second line agent and clinical data will be collected.
Interventions
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Second Line ITP agents
The treating physicians will select the second line agent and clinical data will be collected.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages \> 12 months to \<18 years
* Starting a new second line therapy as defined as any therapy except IVIG, steroids, anti-D globulin, or aminocaproic acid
* Starting a single agent/monotherapy
Exclusion Criteria
* Unwillingness to be followed for 1 year
* Physician providing care is unwilling to participate
* Patient is starting multiple second line agents simultaneously
1 Year
18 Years
ALL
No
Sponsors
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Terrana ITP Research Fund
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Rachael Grace
Principal Investigator, PKD Natural History Study
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Mattel Children's Hospital
Los Angeles, California, United States
Children's Hospital of Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital
Palo Alto, California, United States
UC Davis Medical Center
Sacramento, California, United States
UCSF School of Medicine
San Francisco, California, United States
Colorado Children's Hospital
Denver, Colorado, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
St. John Hospital & Medical Center
Detroit, Michigan, United States
Goryeb Children's Hospital
Morristown, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
New York-Presbyterian University Hospital of Columbia and Cornell
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health and Sciences University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Hasbro Children's Hospital
Providence, Rhode Island, United States
St. Jude's Hospital
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Seattle Children's
Seattle, Washington, United States
McMaster Children's Hospital
Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
U. de Montreal CHU St. Justine
Montreal, Quebec, Canada
Countries
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References
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Grace RF, Shimano KA, Bhat R, Neunert C, Bussel JB, Klaassen RJ, Lambert MP, Rothman JA, Breakey VR, Hege K, Bennett CM, Rose MJ, Haley KM, Buchanan GR, Geddis A, Lorenzana A, Jeng M, Pastore YD, Crary SE, Neier M, Neufeld EJ, Neu N, Forbes PW, Despotovic JM. Second-line treatments in children with immune thrombocytopenia: Effect on platelet count and patient-centered outcomes. Am J Hematol. 2019 Jul;94(7):741-750. doi: 10.1002/ajh.25479. Epub 2019 Apr 29.
Grace RF, Despotovic JM, Bennett CM, Bussel JB, Neier M, Neunert C, Crary SE, Pastore YD, Klaassen RJ, Rothman JA, Hege K, Breakey VR, Rose MJ, Shimano KA, Buchanan GR, Geddis A, Haley KM, Lorenzana A, Thompson A, Jeng M, Neufeld EJ, Brown T, Forbes PW, Lambert MP. Physician decision making in selection of second-line treatments in immune thrombocytopenia in children. Am J Hematol. 2018 Jul;93(7):882-888. doi: 10.1002/ajh.25110. Epub 2018 May 6.
Other Identifiers
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P00008709
Identifier Type: -
Identifier Source: org_study_id
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