Phase 2
N=60
Eltrombopag for Post Transplant Thrombocytopenia
Thrombocytopenia
Bottom Line
View on ClinicalTrials.gov: NCT01000051 ↗Enrolled (actual)
60
Serious AEs
30.4%
Results posted
Jul 2019
Primary outcome: Primary: Comparing the Efficacy of Eltrombopaq and Placebo — 15; 5; 9; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Eltrombopag (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparing the Efficacy of Eltrombopaq and Placebo |
15; 5; 9; 0; 15; 12 | — |
Summary
The goal of this clinical research study is to learn if eltrombopag can help to improve platelet counts in patients with low platelets after they have had a stem cell transplant. The safety of this drug will also be studied.
Eligibility Criteria
Inclusion Criteria
- Patients >/= 35 days post HCT with Platelet count /= 1.5 x 10^9/l anytime within the last seven days before enrollment. Patients can be on myeloid or erythroid growth factors for example filgrastim), and
- Age >/= 18
Exclusion Criteria
- Recurrence or progression of primary malignancy after HCT
- ALT >/= 2.5 times the ULN
- Serum bilirubin >2mg/dl (unless due to Gilbert's syndrome)
- Documented deep vein thrombosis within 1 year before enrollment on the study, except if upper arm thrombosis related to central venous catheters, within 3 months before enrollment on the study.
- ECOG Performance status >2
- Pregnancy: Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. A woman of child-bearing potential is defined as a woman who has not been naturally post-menopausal for at least 12 consecutive months or with no previous surgical sterilization. A negative pregnancy test result will be required before any study drug is given.
Data sourced from ClinicalTrials.gov (NCT01000051). 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.