Actively Recruiting
Romiplostim N01 Combined With Glucocorticoids as First-Line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia (ITP) A Multicenter, Interventional Trial
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-05-28
129
Participants Needed
1
Research Sites
30 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
Researchers are evaluating the safety and effectiveness of romiplostim N01 combined with glucocorticoids as a first treatment for adults newly diagnosed with primary immune thrombocytopenia (ITP). This prospective, multicenter, randomized trial involves adults aged 18 to 75 who have not received prior ITP treatment and aims to assess continuous remission after six months of treatment. Participants are randomly assigned in a 2:1 ratio to either receive romiplostim N01 plus glucocorticoids or glucocorticoids alone. The glucocorticoid used is dexamethasone at 40 mg per day for four days, repeated once if no response by day 10. Romiplostim N01 is administered as a weekly subcutaneous injection starting at 3 μg/kg, with dose adjustments based on platelet counts over up to six months. Follow-up continues up to 24 weeks after treatment ends. During the study, participants will have their platelet counts, bleeding symptoms, and side effects monitored regularly. Researchers will track adverse events, medications, and treatments throughout the trial. The main outcome is the proportion of patients who achieve continuous remission at six months, along with other measures like response rates at one, three, six, nine, and twelve months, bleeding severity, and safety data.
CONDITIONS
Brief 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 informed consent before enrollment
- Age 18 to 75 years
- Diagnosed with primary immune thrombocytopenia within 3 months before randomization
- No prior treatments for ITP
- No previous romiplostim treatment
- ECOG performance status score between 0 and 2
- Platelet count below 30 x 10^9/L
- Expected survival of at least 12 weeks at screening
- Agree to reliable contraceptive measures if of reproductive age
- Voluntary participation with good compliance
You will not qualify if you...
- Secondary thrombocytopenia from other causes like leukemia or myelodysplastic syndrome
- Previous splenectomy before first treatment
- Prior ITP drug treatment before study start
- Use of c-Mpl stimulating drugs 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 anticoagulants at screening
- Severe cardiovascular diseases increasing thromboembolic risk
- Secondary thrombocytopenia due to autoimmune diseases like lupus or Sjogren's syndrome
- Positive HIV, syphilis, hepatitis B or C markers beyond lab limits
- Participation in other clinical trials within 3 months before first treatment
- Pregnancy, lactation, or pregnancy plans
- Lack of effective contraception for fertile participants
- Severe drug allergies to glucocorticoids, romiplostim, or study components
- Mental incapacity preventing compliance
- Judged unsuitable by the researcher to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive dexamethasone for one or two cycles and, if assigned to the experimental group, also receive weekly subcutaneous injections of romiplostim N01 for up to 6 months with dose adjustments based on platelet counts.
Weekly visits for up to 6 months
Duration - 24 weeks after end of treatment
Participants are followed up for safety and efficacy assessments including platelet counts, bleeding symptoms, and adverse events through clinical or telephone visits after treatment ends.
Visits as needed for adverse event follow-up and clinical evaluation
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
Y
Yunfei Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here