Status:
COMPLETED
Sirolimus Treatment for Newly Diagnosed Primary Acquired PRCA
Lead Sponsor:
Bing Han
Conditions:
Pure Red Cell Aplasia, Acquired
Eligibility:
All Genders
18-88 years
Phase:
PHASE4
Brief Summary
Pure red cell aplasia (PRCA) is a kind of anemia characterized by severe reticulocytopenia and obvious bone marrow erythroblastic cells decreased. Cyclosporine A and /or steroids are the first line th...
Detailed Description
Pure red cell aplasia (PRCA) is a rare normocytic normochromic anemia with reticulocytopenia, characterized by a reduction of erythroid precursors from the bone marrow, could be divided into congenita...
Eligibility Criteria
Inclusion
- age \>18 years old.
- hemoglobin (Hb) \<90 g/L before treatment.
- no history of immunosuppression therapy prior to sirolimus or CsA treatment.
- adequate hepatic functions with alanine transaminase (ALT)/aspartate. transaminase (AST) levels within 3 times of the normal upper limit and total bilirubin levels within 2 times of the normal upper limit.
- documented patient consent.
Exclusion
- diagnosis of secondary aPRCA.
- history of treatment with immunosuppression therapy before enrollment.
- history of leukemia, stem cell transplantation, or treatment-related myelodysplastic syndromes (MDS).
- creatinine/transaminase ≥ 3 normal upper limit.
- complicated with active or uncontrolled infections or uncontrolled cardiovascular disease.
- presence of other diseases that may cause anemia.
- presence of malignancies.
- pregnant and lactating women.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04470804
Start Date
July 1 2020
End Date
July 31 2022
Last Update
February 28 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100730