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This study evaluates standard immunosuppressive therapy combined with Romiplostim N01 as a first-line treatment for severe aplastic anemia (when the bone marrow cannot make enough blood cells). Patients aged 12 and older who cannot undergo a stem cell transplant can take part. It is being conducted in Phase 2 and is still enrolling participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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 written informed consent. Exclusion Criteria: * 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 * Allergy to ALG * Presence of uncontrolled active infection * Presence of uncontrolled hypertension (≥140/90mmHg), diabetes mellitus (fasting blood glucose≥ 7.0 mmol/L or random blood glucose ≥ 11.1 mmol/L) * Abnormal liver and kidney function: Aspartate Transaminase (AST) or Alanine Transaminase (ALT) \> 3 ULN, creatinine ≥ 2.5 ULN * History of chemoradiotherapy for malignant solid tumors * History of other systemic serious illnesses * Females who are pregnant/lactating or need pregnancy * Patients considered to be ineligible for the study by the investigator for reasons other than the above