Sirolimus Treatment for Newly Diagnosed Primary Acquired PRCA

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bing Han
• Treatments: Cyclosporine; Cyclosporins; Sirolimus

Criteria

Inclusion Criteria:

1. Newly diagnosed primary acquired PRCA with no immunosuppression therapy.

2. Excluding other diseases which might cause hematological abnormalities.

3. With no abnormal heart function, active infection, and malignant tumors.

4. Written informed consent.

Exclusion Criteria:

1. NOT newly diagnosed primary acquired PRCA.

2. Previous treatment of immunosuppression therapy.

3. Patients who are under 18-year-old or over 70-year-old.

4. Pregnant or lactating.

5. Serious kidney and liver dysfunction (creatinine/transaminase ≥ 3 normal upper limit.

6. Serious heart function failure.

7. Merge on uncontrolled infection, other serious system diseases, and malignant tumors.

8. Patients unwilling to or unable to comply with the protocol.