NCT06686927 Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP
| NCT ID | NCT06686927 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Primary Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2025-09-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2024-11-20 with a primary completion date of 2025-09-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Participants must sign a written informed consent prior to enrollment; 2. Ages 18-75; 3. Platelet count \<10×10\^9/L with active bleeding or bleeding score ≥5; 4. No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments; 5. No prior splenectomy or at least one first-line ITP treatment or emergency treatment; 6. No prior romiplostim treatment; 7. ECOG PS score: 0-2; 8. Female participants of childbearing potential must agree to use reliable contraception (including male or female condoms, contraceptive foam, contraceptive jelly, contraceptive patches, contraceptive cream, contraceptive suppositories, abstinence, and placement of intrauterine contraceptive devices) throughout the study; women who have had a hysterectomy, bilateral oophorectomy, bilateral salpingo-oophorectomy, or have been postmenopausal for more than 1 year, and men who have had bilateral vasectomy or vasectomy are excluded; 9. Voluntary participation in this study and good compliance. Exclusion Criteria: 1. Individuals with the following hematological disorders other than ITP, including but not limited to leukemia, thrombocytopenia caused by cancer treatment, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome; 2. Individuals with a history of thrombosis; 3. Pregnant or lactating individuals; 4. Individuals with severe cardiopulmonary insufficiency; 5. Individuals with severe or uncontrollable infections; 6. Individuals with viral infections; 7. Individuals who cannot comply due to psychological reasons; 8. Individuals who are deemed unsuitable for participation in the study by the investigator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06686927 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Primary Immune Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06686927 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06686927 currently recruiting?
Yes, NCT06686927 is actively recruiting participants. Contact the research team at lancet.tang@qq.com for enrollment information.
Where is the NCT06686927 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06686927 clinical trial?
NCT06686927 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 36 participants.