Status:
COMPLETED
CsA+ATG+AVA vs. CsA+AVA for the Treatment of Newly-diagnosed SAA in the Elderly
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Aplastic Anemia
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
This is a multicenter, prospective, randonmized study. Our previous retrospective study showed that for SAA patients who were intolerant to ATG, CsA+ eltrombopag (EPAG) had similar efficacy to CsA+ATG...
Detailed Description
Aplastic anemia (AA) can be divided into severe AA (SAA) and non-severe AA (NSAA), according to the severity of the disease. For SAA patients with o condition of hematopoietic stem cell transplantatio...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed severe aplastic anemia, aged greater than 60 years.
- Patients met the diagnostic criteria of severe aplastic anemia (SAA).
- Complete all screening assessments as outlined in the test protocol.
- Without or with no more than 1 month treatment of ciclosporine, tacrolimus, glucocortocoid, or TPO-RAs.
- Agree to sign the informed consent form.
Exclusion
- Known diagnosis of congenital hematopoietic failure disorders (e.g. Fanconi anemia) and other causes of cytopenia.
- Patients with uncontrolled bleeding and/or infection despite standard treatment.
- Patients with previous history of hematopoietic stem cell transplantation.
- Patients with previous history of thrombosis in 1 year.
- Patients with concurrent malignancy.
- Those who are considered unsuitable for enrollment by the investigator.
- Abnormal renal function: creatinine \> 1.2 normal upper limit, albumin \< 0.9 normal lower limit, or CLcr \< 30 ml/min.
- Abnormal liver function: transaminase \> 2.5 normal upper limit, or tota bilirubin \> 2.5 normal upper limit.
- Patients with severe heart, liver or renal disease.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2025
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05996393
Start Date
September 15 2023
End Date
February 27 2025
Last Update
April 30 2025
Active Locations (1)
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1
Peking union medical college hospital
Beijing, China