Actively Recruiting
Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-01-22
36
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
Q
Qilu Hospital of Shandong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if romiplostim N01 works to treat severe primary immune thrombocytopenia in adults. It will also learn about the safety of romiplostim N01. The main question it aims to answer is: TO evaluate the effectiveness of the combination treatment of glucocorticoids, gamma globulin and romiplostim N01 in patients with severe primary immune thrombocytopenia during the initial treatment period for one month. Participants will: Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month. IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days. Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.
CONDITIONS
Official Title
Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must sign a written informed consent prior to enrollment
- Ages 18 to 75 years
- Platelet count less than 10 x 10^9/L with active bleeding or bleeding score of 5 or higher
- No contraindications to steroids, romiplostim, or IVIG and willingness to receive these treatments
- No prior splenectomy or at least one first-line ITP or emergency treatment
- No prior romiplostim treatment
- ECOG performance status score of 0 to 2
- Female participants of childbearing potential must agree to use reliable contraception during the study; women who had hysterectomy, bilateral oophorectomy, bilateral salpingo-oophorectomy, or postmenopausal for more than 1 year, and men with bilateral vasectomy are excluded
- Voluntary participation and good compliance
You will not qualify if you...
- Presence of other hematological disorders aside from ITP such as leukemia, cancer treatment-related thrombocytopenia, myeloproliferative diseases, multiple myeloma, or myelodysplastic syndrome
- History of thrombosis
- Pregnant or lactating individuals
- Severe cardiopulmonary insufficiency
- Severe or uncontrollable infections
- Viral infections
- Inability to comply due to psychological reasons
- Deemed unsuitable for the study by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
L
Liang Tang
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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