Phase 2
N=20
Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP)
Immune Thrombocytopenia
Bottom Line
View on ClinicalTrials.gov: NCT00902018 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Number of Patients for Whom Eltrombopag Increases the Platelet Count to > 50,000/uL — 6; 3; 6; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Eltrombopag (Drug); Romiplostim (Drug); healthy controls (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients for Whom Eltrombopag Increases the Platelet Count to > 50,000/uL |
6; 3; 6; 3 | — |
| PRIMARY Number of Patients Who Received Romiplostim and Increased Their Platelet Counts to > 50,000/uL |
3; 3 | — |
| SECONDARY How Many Patients Developed SAEs and/or Abnormal Liver Tests to a Level > 2 Times the Upper Limit of Normal |
1; 0; 1; 0; 0; 0 | — |
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 Administration (FDA) for the treatment of low platelets in patients with chronic ITP. It is being further studied by GlaxoSmithKline (now Novartis) in other conditions associated with low platelets. This research study is being done because eltrombopag has been shown to increase platelet counts in a different way than other therapies for ITP. The investigators want to further study how eltrombopag and romiplostim affect subjects and their platelets to determine how the study drug should best be used in ITP treatment.
Eligibility Criteria
Inclusion Criteria
- 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 three times upper limit of normal (ULN)
- Creatinine > two times upper limit of normal (ULN)
Data sourced from ClinicalTrials.gov (NCT00902018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.