Status:
COMPLETED
Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP)
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to further evaluate the effects that eltrombopag (and romiplostim) have on platelets in subjects with chronic ITP. Eltrombopag is approved by the Food and Drug Administrat...
Detailed Description
The B-cell lymphoma extra large (Bcl-xL/Bak) balance has been identified as an intrinsic mechanism that is critical in determining platelet lifespan (Mason, Cell 2007). There is evidence that Bcl-xL p...
Eligibility Criteria
Inclusion
- Subject has signed and dated a written informed consent
- Male or female adults (≥18 years) diagnosed with either primary ITP according to the American Society for Hematology or British Committee for Standards in Haematology (ASH/BCSH) guidelines \[Blood, 1996; British Journal of Haematology, 2003\] for at least three months prior to study entry or with ITP secondary to Evans syndrome, systemic lupus erythematosus (SLE), or Common Variable Immunodeficiency (including hypogammaglobulinemia).
- Subjects must have responded with a platelet count \> 30,000/µL to a previous ITP therapy including thrombopoietic agents.
- Platelet count \< 30,000/µL
- Female subjects of childbearing potential are practicing an acceptable method of contraception or are completely abstinent from intercourse.
Exclusion
- Active infection
- Previously treated with thrombopoietic agents IF either no response at a therapeutic dose (peak platelet count \< 50k) OR treatment with the agent within the past 4 weeks
- Currently treated with concomitant ITP medication that has not been stable in dose for at least 2 weeks - only prednisone, azathioprin, and danazol are allowed.
- Female subjects who are nursing or pregnant
- Thrombosis of any kind within past 6 months or on blood thinners because of thrombosis.
- Intravenous Immunoglobulin (IVIG), IV anti-D, bolus corticosteroids or vinca alkaloids within the past week
- Other cytotoxic or immunosuppressive ITP therapy within the past 8 weeks or rituximab within the past 12 weeks
- Active non-dermatologic malignancy defined as presence of known tumor ie. visible by radiography or evident on blood or bone marrow testing OR receiving chemotherapy within past 2 months
- Hemoglobin \< 10 gm/dl or white blood cell count \< 2,500/ul
- Liver function tests (ALT, Aspartate Aminotransferase (AST), or total bilirubin) \> three times upper limit of normal (ULN)
- Creatinine \> two times upper limit of normal (ULN)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00902018
Start Date
January 1 2009
End Date
September 7 2015
Last Update
March 18 2019
Active Locations (1)
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1
Weill Cornell Medical College
New York, New York, United States, 10065