Actively Recruiting
Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Multicenter, Interventional Trial
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-05-28
129
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
W
Weifang People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This prospective, multicenter, randomized study aim to evaluate the efficacy and safety of romiplostim N01 combined with glucocorticoids as the first-line treatment for newly diagnosed adult primary immune thrombocytopenia (ITP).
CONDITIONS
Official Title
Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Multicenter, Interventional Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before enrollment
- Age between 18 and 75 years old
- Clinically diagnosed with primary immune thrombocytopenia for less than 3 months before randomization
- No prior treatments for immune thrombocytopenia
- No previous treatment with romiplostim
- ECOG performance status score of 0 to 2
- Platelet count less than 30 × 10⁹/L
- Expected survival of at least 12 weeks at screening
- For those of reproductive age, agreement to use reliable contraception during the study
- Voluntary participation with good compliance and signed informed consent
You will not qualify if you...
- Having secondary thrombocytopenia other than primary immune thrombocytopenia
- Previous splenectomy before first treatment
- Prior immune thrombocytopenia drug treatment before first administration
- Use of drugs stimulating thrombopoietin receptor within 4 weeks before first treatment
- Use of hematopoietic growth factors within 4 weeks before first treatment
- Use of antibody drugs within 14 weeks before first treatment
- Use of Chinese herbal or nutritional supplements to increase platelets within 1 week before first treatment
- History or current arterial or venous thrombosis, or use of anticoagulant or antiplatelet drugs at screening
- History of severe cardiovascular diseases increasing thromboembolism risk
- Secondary thrombocytopenia from autoimmune diseases like lupus or antiphospholipid syndrome
- Positive HIV, syphilis, hepatitis B or C tests beyond study limits
- Participation in other clinical studies within 3 months before first treatment
- Pregnant, breastfeeding, or planning pregnancy
- Not fully using contraceptive measures if fertile
- History of severe allergic reactions to glucocorticoids, romiplostim, or study drug components
- Mental incapacity preventing compliance
- Investigator judgment deeming unsuitability for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
L
Lei Zhang
CONTACT
Y
Yunfei Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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