NCT06613880 Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia
| NCT ID | NCT06613880 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Aplastic Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-10-24 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2024-10-24 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Jun Shi, PhD
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT06613880 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Aplastic Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06613880 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06613880 currently recruiting?
Yes, NCT06613880 is actively recruiting participants. Contact the research team at zhanglele@ihcams.ac.cn for enrollment information.
Where is the NCT06613880 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06613880 clinical trial?
NCT06613880 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Jun Shi, PhD at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 48 participants.