A Prospective, Single Center, Single-arm Study on the Efficacy and Safety of Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Regenerative Medicine Center and Red Blood Cell Disorders Center
RECRUITING
Tianjin
Contact Information
Primary
Lele Zhang, PhD
zhanglele@ihcams.ac.cn
15811139278
Backup
Meili Ge, PhD
Time Frame
Start Date: 2024-10-24
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 48
Treatments
Experimental: p-ALG+Romiplostim N01+CsA
The maximum screening period was 4 weeks, and after entering the treatment period, the patients were treated with p-ALG combined with cyclosporine and Romiplostim N01. Symptomatic leukocyte elevation, blood transfusion support, and anti-infective therapy are allowed during this period, according to the patient's blood routine. If a patient has a serious adverse event during treatment, it will be treated according to the criteria for suspension and recovery.
Related Therapeutic Areas
Sponsors
Collaborators: Qilu Pharmaceutical Co., Ltd.
Leads: Institute of Hematology & Blood Diseases Hospital, China