Actively Recruiting
A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-10-26
129
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
T
The Second Affiliated Hospital of Kunming Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a multicenter interventional research on the first-line treatment of newly diagnosed adult patients with immune thrombocytopenia (ITP) using romiplostim N01 in combination with glucocorticoids. The primary endpoint of this study is to assess the efficacy of romiplostim N01 combined with glucocorticoids in untreated newly diagnosed adult ITP patients after 6 months of administration. The subjects will be divided into the experimental group and the control group for treatment. Experimental group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously. Simultaneously, romiplostim N01 is administered at an initial dose of 3µg/kg, by subcutaneous injection, once a week, for a maximum of 6 months. Control group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously.
CONDITIONS
Official Title
A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
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 splenectomy or first-line ITP treatment or emergency treatment
- No previous romiplostim treatment
- ECOG performance status score of 0 to 2
- Platelet count less than 30 x 10^9/L
- Expected survival of at least 12 weeks at screening
- Agree to use reliable contraception throughout the study if of reproductive age (exceptions for those sterilized or postmenopausal)
- Willing to participate voluntarily and comply with the study
You will not qualify if you...
- Having other blood system diseases besides ITP, such as leukemia or myelodysplastic syndrome
- Previous splenectomy before first administration
- Prior ITP drug treatment or emergency treatment before first administration
- Used drugs stimulating thrombopoietin receptor within 4 weeks before first administration
- Received hematopoietic growth factors within 4 weeks before first administration
- Received antibody drugs like rituximab within 14 weeks before first administration
- Used Chinese herbal or nutritional supplements to increase platelets within 1 week before first administration (except vitamins and minerals)
- History or current arterial or venous thrombosis or using anticoagulants or antiplatelet drugs at screening
- Severe cardiovascular diseases increasing thromboembolism risk
- Secondary thrombocytopenia caused by autoimmune diseases
- Positive tests for HIV, syphilis, hepatitis B or C exceeding lab limits
- Participation in other clinical studies within 3 months before first administration
- Pregnant, lactating, or planning pregnancy
- Fertile persons not fully using contraception
- History of severe allergic reactions to glucocorticoids, romiplostim, or study components
- Mental conditions preventing compliance
- Judged unsuitable by researchers to participate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
L
Lei Zhang, MD
CONTACT
Y
Yunfei Chen, MD
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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