ICON1: Treatment Decisions and Outcomes in Pediatric Refractory ITP



Status:Completed
Conditions:Infectious Disease, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases
Healthy:No
Age Range:1 - 18
Updated:1/26/2019
Start Date:August 2013
End Date:April 2017

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ICON1: Physician Treatment Decisions and Patient-Reported Outcomes in Pediatric Refractory Immune Thrombocytopenia

The purpose of this study is to understand physician treatment decisions in selecting
specific second line treatments in pediatric ITP and to determine the effectiveness of
different second line ITP treatments. Eligible patients are those ages 1-18 years who are
starting on a new second line treatment for ITP, defined as any treatment other than IVIG,
steroids, anti-D globulin, or aminocaproic acid. Enrolled patients remain on the study for
approximately one year.

The purpose of this observational study is to model factors that determine physician
treatment decisions in selecting specific second line agents in pediatric ITP and to
determine the comparative effectiveness of second line ITP treatments by bleeding measures,
platelet counts, and patient reported outcome measures. This prospective observational,
longitudinal, multicenter cohort study will aim to collect routine clinical care data,
quality of life information from patients, and decision making data from clinicians at
enrollment and at regular clinical intervals for at least one year. The primary and secondary
objectives are as follows:

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.

Inclusion Criteria:

- Immune Thrombocytopenia or Evans Syndrome

- 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:

- Evans Syndrome with a history of or current evidence of autoimmune hemolytic anemia

- Unwillingness to be followed for 1 year

- Physician providing care is unwilling to participate

- Patient is starting multiple second line agents simultaneously
We found this trial at
28
sites
5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: George Buchanan, MD
Phone: 214-648-3322
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Melissa Rose, DO
Phone: 614-722-3550
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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702 Barnhill Drive
Indianapolis, Indiana 46202
Principal Investigator: Kerry Hege, MD
Phone: 317-944-8784
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Indianapolis, IN
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: Diane Nugent, MD
Phone: 714-532-8459
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Michele Lambert, MD
Phone: 215-590-0431
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Sacramento, California 95814
Principal Investigator: Anajli Pawar, MD
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Principal Investigator: Carolyn Bennett, MD
Phone: 404-727-3681
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Rachael F Grace, MD, MMSc
Phone: 617-355-7203
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Alexis A Thompson, MD, MPH
Phone: 312-227-4811
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Cincinnati, Ohio 45229
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Denver, Colorado 80045
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Detroit, Michigan 48236
Principal Investigator: Adonis Lorenzana, MD
Phone: 313-647-3214
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Jennifer Rothman, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Hamilton, Ontario
Principal Investigator: Vicky Breakey, MD
Phone: 905-521-2100
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Jennifer Despotovic, DO
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: Kimo Stine, MD
Phone: 501-364-1691
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Los Angeles, California 90095
Principal Investigator: Pamela Kempert, MD
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Memphis, Tennessee 38105
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Morristown, New Jersey 07962
Principal Investigator: Michele Neier, MD
Phone: 973-971-6720
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Cindy Neunert, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, New York 10065
Principal Investigator: Catherine McGuinn, MD
Phone: 212-746-3978
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Oakland, California 94609
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Palo Alto, California 94304
Principal Investigator: Michael Jeng, MD
Phone: 650-723-0567
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Palo Alto, California 94304
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Portland, Oregon 97227
Principal Investigator: Kristina Haley, DO
Phone: 503-494-0829
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Providence, Rhode Island 02903
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San Francisco, California 94143
Principal Investigator: James Huang, MD
Phone: 415-476-3831
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Seattle, Washington 98115
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