About this trial
This prospective, single center, single-arm study aims to evaluate the efficacy and safety of anti-human T lymphocyte porcine immunoglobulin (p-ALG) in combination with cyclosporine and Romiplostim in treating severe aplastic anemia (SAA). It will include 48 patients with newly diagnosed SAA.
Eligibility criteria
Qualifiers
Age ≥ 12 years
Diagnosis of severe or very severe aplastic anemia
Patients are unconditionally or unacceptable undergoing allogeneic hematopoietic stem cell transplantation
ECOG performance status ≤2
Disqualifiers
Received > 4 weeks of TPO-RA drug before treatment
Received > 4 weeks of immunosuppressive therapy before treatment
History of thromboembolic disease
Intolerance to Romiplostim N01 or cyclosporine
Trial design
Treatments tested in this trial
- standard IST combined with Romiplostim N01
Treatment groups
Sponsors and collaborators
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Collaborator