CompletedNot Applicable

ICON1: Treatment Decisions and Outcomes in Pediatric Refractory ITP

United States120 participantsStarted 2013-08

Plain-language summary

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.

Who can participate

Age range1 Year – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

change from baseline in patient reported outcomes

Timeframe: Enrollment, 1 and 12 months

change from baseline in bleeding assessment

Timeframe: Enrollment, 1, 6, and 12 months

change from baseline in platelet count

Timeframe: over 1 year

Trial details

NCT IDNCT01971684

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-04

View on ClinicalTrials.gov More Immune Thrombocytopenia trials