Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder o… (NCT01520909) | Clinical Trial Compass
CompletedPhase 3
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.
United States, Argentina92 participantsStarted 2012-03
Plain-language summary
The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag.
Who can participate
Age range1 Year – 17 Years
SexALL
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Inclusion Criteria:
* Written informed consent must be obtained from the patient's guardian and accompanying informed assent from the patient (for children over 6 years old)
* Patients must be between 1 year and \<18 years of age at Day 1
* Patients will have a confirmed diagnosis of chronic ITP for at least 1 year, at screening, according to the guidelines published in the International Working Group Report
* A peripheral blood smear or bone marrow examination will support the diagnosis of ITP with no evidence of other causes of thrombocytopenia.
* Patients must be refractory or have relapsed after at least one prior ITP therapy, or patients must be unable, for a medical reason, to continue other ITP treatments.
* Patients must have a Day 1 (or within 48 hours prior) platelet count \<30 Gi/L.
* Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 2 weeks prior to Day 1, or these therapies must have been completed at least 1 week prior to Day 1 and have been clearly ineffective.
* Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to Day 1.
* Patients treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to Day 1.
* Patients must have a complete blood count (CBC) not suggestive of another hematological disorder.
* Patients must have the following laboratory resul…
What they're measuring
1
Number of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) for at Least 6 Out of 8 Weeks, Between Weeks 5 and 12 of Part 1