Status:
UNKNOWN
Avatrombopag Usage in NSAA
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Aplastic Anemia
Drug Effect
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a multicenter, open-label, prospective one arm study to explore the efficacy and safety of Avatrombopag in non-severe aplastic anemia. Patients meeting the inclusion and exclusion criteria wou...
Eligibility Criteria
Inclusion
- Patients diagnosed to be non-severe aplastic anemia
- Patients have at least one of the followings: ①absolute neutrophil count \< 1.5×109/L, ②platelet count \< 30×109/L, ③ hemoglobin level \< 100g/L
- Patients have 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);
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- Patients 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 (MDS, AML) on cytogenetics;
- Presence with PNH clone ≥50%;
- Patients received HSCT before;
- Uncontrolled infection or bleeding with standard treatment;
- Allergic to Avatrombopag or accessories;
- HIV, HCV or HBV active infection or liver cirrhosis or portal hypertension;
- 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, unstable angina pectoris, uncontrolled hypertension(\>180/100mmHg)，pulmonary artery hypertension;
- Have any concomitant malignancies within 5 years expect for local basal cell carcinoma of the skin;
- Past history of thromboembolic event, heart attack or stroke (including anti-phospholipid antibody syndrome) and current use of anticoagulants;
- Pregnant or nursing (lactating) woman;
- Have attended other clinical trials within 3 months;
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04728789
Start Date
February 1 2021
End Date
June 30 2023
Last Update
January 28 2021
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100730