Status:
COMPLETED
Safety and Efficacy of Eltrombopag at Escalated Doses
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Novartis
Conditions:
Immune Thrombocytopenia
Platelet Disorder
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
Study rationale is based on the data that in previous clinical studies of eltrombopag in ITP there are some patients who have been reported as non responders at the maximal approved dose of 75 mg dail...
Detailed Description
Preliminary data in pediatric patients (who seem to metabolize eltrombopag differently especially at younger ages) find that in the middle and lowest age cohort, even doses of 75 mg were often insuffi...
Eligibility Criteria
Inclusion
- Subject or their parent/ guardian has signed and dated a written informed consent
- Male and Females aged 12 years or older diagnosed with chronic ITP according to the new consensus guidelines
- No indication of a disease which may cause thrombocytopenia other than ITP----no specific testing required
- Subjects with thrombocytopenia ≤ 50,000 /uL after at least 21 days of daily dosage with eltrombopag 75mg
- Stable dosage of concomitant treatments for ITP
- ≥ 2 weeks or longer (corticosteroids);
- At least 2 weeks from rescue therapy for ITP (WinRho, Intravenous Immunoglobulin (IVIG), corticosteroids, platelet transfusion)
- At least 4 weeks from rituximab treatment
- Pregnant or Lactating Women are excluded
- Women of child-bearing age with a negative pregnancy test within 7 days of enrollment and who agree to use acceptable methods of birth control will be eligible for this study
- Female subjects or female partners of male subjects must either be of non-child bearing potential (hysterectomy, bilateral ovariectomy, bilateral tubal ligation or post menopausal for more than one year) OR, if of child bearing potential, using one of the following highly effective methods of contraception.
- complete abstinence from intercourse
- Intrauterine device (IUD)
- Two forms of barrier contraception. diaphragm plus spermicide, or for males condoms plus spermicide.
- Male partner is sterile and is the only partner of the female.
- Systemic contraceptives (combined oral progesterone only)
Exclusion
- Previous history of eltrombopag-related liver function test (LFT) elevation that required interruption of treatment
- Previous history of immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to eltrombopag
- HIV Infection
- History of Arterial of Venous Thrombosis within the past year or requiring ongoing therapy
- Active Hepatitis C infection
- Treatment with medications that affect platelet function ( including but not limited to Aspirin, Clopidogrel and /or NSAIDs) or anti-coagulant medications
- Elevated Aspartate Aminotransferase(AST/ALT) or Creatinine \> 1.5 times upper limit of normal in 4 weeks prior to enrollment\*
- Abnormalities in white blood cell count (WBC), automatic neutrophil count (ANC), and Hemoglobin \> 1.5 times upper or lower limit of normal\*
- \* Subjects can be rescreened to be included
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2017
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01880047
Start Date
February 1 2013
End Date
October 16 2017
Last Update
June 11 2019
Active Locations (1)
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1
Weill Cornell Medicine
New York, New York, United States, 10065