Actively Recruiting
Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-12-04
48
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
Q
Qilu Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Regenerative Medicine Center and Red Blood Cell Disorders Center
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
L
Lele Zhang, PhD
CONTACT
M
Meili Ge, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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