CompletedPhase 4

Sirolimus Treatment for Newly Diagnosed Primary Acquired PRCA

China56 participantsStarted 2020-07-01

Plain-language 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 therapy but some patients were refractory or intolerance to the treatment. The effects of the second line therapy are also not satisfactory and sometimes not available. The investigators aim to explore the efficacy and side-effect of sirolimus for newly diagnosed primary acquired PRCA.

Who can participate

Age range18 Years – 88 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Hemoglobin level

Timeframe: 6 months

Trial details

NCT IDNCT04470804

SponsorBing Han

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-30

View on ClinicalTrials.gov More Pure Red Cell Aplasia, Acquired trials