CsA+EPAG/HPAG+Romiplostim N01 in Newly-diagnosed SAA/TD-NSAA
NCT07558434 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43
Last updated 2026-04-30
Summary
This study aimed to explore the efficacy and safety of cyclosporine (CsA)
+eltrombopag (EPAG)/hetrombopag (HPAG)+romiplostim N01 in the treatment of newly-diagnosed transfusion-dependent aplastic anemia (TD-NSAA) and severe aplastic anemia (SAA)
Conditions
- Severe Aplastic Anemia (SAA)
- Transfusion-dependent Non-severe Aplastic Anemia
Interventions
- DRUG
-
Cyclosporine (CsA)
CsA 3-5mg/kg/d, trough concentration 100-200ng/ml
- DRUG
-
thrombopoietin receptor agonist (TPO-RA)
Eltrombopag 50mg/d, increased by 25mg every two weeks Hetrombopag 7.5mg/d, increased by 2.5mg every two weeks
- DRUG
-
Romiplostim N01
Romiplostim N01 20µg/kg, subcutaneously, once a week
Sponsors & Collaborators
-
Peking Union Medical College Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2028-12-31
- Completion
- 2029-12-31
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