Actively Recruiting
Study of Glucocorticoids Combined With Gamma Globulin and Romiplostim N01 for Initial Treatment of Severe Primary Immune Thrombocytopenia in Adults
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
Researchers are evaluating the effectiveness and safety of romiplostim N01 combined with glucocorticoids and gamma globulin to treat adults with severe primary immune thrombocytopenia (ITP). This Phase 2 trial focuses on the initial treatment period of one month to see how well this combination works for patients with low platelet counts and active bleeding symptoms. Participants will receive romiplostim N01 by subcutaneous injection once a week at a starting dose of 1 bcg/kg, beginning on the third day of intravenous immunoglobulin (IVIG) treatment. IVIG is given intravenously at 400 mg/kg per day for 3 to 5 days. Prednisone, a glucocorticoid, is taken orally or intravenously at 0.8 mg/kg per day for up to one month. This combined treatment approach is studied during the initial one-month treatment phase. During the study, participants will be monitored to assess the total effective rate of treatment after 30 days. Safety and treatment response will be evaluated through clinical assessments and patient compliance. The study includes adults aged 18 to 75 years, and participants must meet specific health and treatment history criteria to join. Researchers will track treatment effects and adverse events throughout the one-month period.
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
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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