Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia
Recruiting
Phase 2
Interventional Study
Aplastic Anemia
TPO Receptor Agonists
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 48 (estimated)
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China · Other
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
* Willing and able to comply with the requirements for this study and w…