Status:
COMPLETED
Efficacy and Safety of Eltrombopag + Tacrolimus in Chinese Refractory or Relapsed Aplastic Anemia Patients
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Aplastic Anemia
Drug Effect
Eligibility:
All Genders
14-85 years
Phase:
PHASE2
Brief Summary
This is a randomized, open-label, phase II study to compare the efficacy of eltrombopag combined with tacrolimus to eltrombopag alone in Chinese subjects with refractory or relapsed aplastic anemia. T...
Eligibility Criteria
Inclusion
- Patient with a previous diagnosis of aplastic anemia and had no response or relapsed following at least one treatment course in a period time of ≥ 6 months of immunosuppression containing CsA or CsA+anti-thymocyte globulin (ATG);
- Current diagnosis of aplastic anemia by bone marrow biopsy;
- did not receive HSCT nor were HSCT candidates;
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- Patient with QTcF (Fridericia's QT correction formula) at screening \<450 msec, or \<480 msec with bundle branch block, as determined via the mean of a triplicate ECG and assessed at site.
- Subjects are able to understand and comply with protocol requirements and instructions and have signed and dated informed consent.
Exclusion
- Congenital aplastic anemia;
- Presence of chromosomal aberration;
- Evidence of a clonal hematologic bone marrow disorder on cytogenetics;
- Have any concomitant malignancies and must be fully recovered from treatment for any other malignancy and have been disease-free for 5 years;
- AST or ALT ≥3 times the upper limit of normal;
- Serum creatinine, total bilirubin, or alkaline phosphatase \>1.5 x ULN;
- Cardiac disorder (NYHA) functional classification Grade II/III/IV;
- Past history of thromboembolic event (including anti-phospholipid antibody syndrome) and current use of anticoagulants;
- Infection not adequately responding to appropriate therapy;
- Other known or suspected underlying primary immunodeficiency;
- Prior treatment with eltrombopag, romiplostim, or any other TPO (thrombopoietin) receptor agonist;
- Pregnant or nursing (lactating) woman;
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04403321
Start Date
July 1 2020
End Date
July 31 2022
Last Update
January 19 2023
Active Locations (1)
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1
Peking union medical college hospital
Beijing, China