Status:
WITHDRAWN
Avatrombopag for the Treatment of Thrombocytopenia After Donor Hematopoietic Stem Cell Transplant
Lead Sponsor:
Ayman Saad
Collaborating Sponsors:
Sobi, Inc.
Conditions:
Platelet Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies the side effects and how well avatrombopag works for the treatment of thrombocytopenia after donor hematopoietic stem cell transplant. Thrombocytopenia is defined as abnorm...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the safety and efficacy of avatrombopag for the treatment of thrombocytopenia after allogenic hematopoietic stem cell transplantation. SECONDARY OBJECTIVE: I. To ...
Eligibility Criteria
Inclusion
- Failure to engraft platelets by day 30 (D30) after hematopoietic cell transplantation (HCT) defined as: Platelet count less than 20,000/uL and patient is still dependent on platelet transfusion support
- Patient must be able to start treatment with avatrombopag within 30-60 days following transplant
- Able to provide written informed consent from patient or legal representative
Exclusion
- Serious uncontrolled infections
- Steroid refractory graft versus host disease (GVHD)
- Patients with thrombotic microangiopathy
- Pregnant or lactating women
- Creatinine clearance \< 30 ml/min
- Active thromboembolism requiring anticoagulation
- Unable to understand the investigational nature of the study or provide informed consent
- Evidence of disease relapse by flow cytometry of chimerisms
- Concomitant use of other thrombopoietin receptor agonists (TPO-RA) medication during the treatment phase of the study or two weeks prior to enrollment
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04312789
Start Date
December 1 2022
End Date
December 31 2022
Last Update
December 9 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.