NCT07788456 Multi-target Drugs Sequential Combination Therapy in Adults Patients With Newly Diagnosed Primary Immune Thrombocytopenia
| NCT ID | NCT07788456 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | ITP - Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2026-06-22 |
| Primary Completion | 2027-05-30 |
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.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 38 participants in total. It began in 2026-06-22 with a primary completion date of 2027-05-30.
⚠ 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
This prospective, single-arm, multicenter, exploratory study will enroll 38 adults patients with newly diagnosed primary immune thrombocytopenia (ITP). Patients will receive standard-dose corticosteroids plus a thrombopoietin receptor agonist (TPO-RA) as initial therapy During the core treatment phase (Weeks 1-12). Corticosteroids will be tapered and discontinued within 8 weeks, whereas TPO-RA treatment will continue for 12 weeks. For patients with treatment failure( defined as platelet count \< 30 × 10\^9/L or less than 2-fold increase of baseline platelet count or bleeding) ,a sequential multitarget combination strategy will be explored in subsequent treatment phases. Specifically, patients with treatment failure after 2 weeks of initial therapy (Weeks 3-12), will receive the ongoing TPO-RA in combination with either rituximab or an anti-CD38 monoclonal antibody（mAb） as sequential combination therapy. During the core treatment follow-up phase (24 weeks), patients with treatment failure will enter the exploratory treatment phase (Weeks 13-36) . Patients who received multi-target drug therapy during the core treatment period will switch to an alternative TPO-RA with cross-administered rituximab and anti-CD38 mAb, while those who did not will receive sequential rituximab or anti-CD38 mAb. Finally, patients will enter the safety follow up period (4 weeks, weeks 37-40).
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years. 2. Confirmed newly diagnosed primary ITP with a platelet count \<30 × 10\^9/L. 3. No prior ITP-related treatment before enrollment, except for standard-dose corticosteroids and/or IVIG for ≤5 days. 4. Able to understand the study and provide signed informed consent.- Exclusion Criteria: 1. Use of corticosteroids or immunosuppressants for a non-ITP condition within 3 months. 2. Contraindication to corticosteroid therapy. 3. Arterial or venous thromboembolic event within 3 months. 4. Pregnant or breastfeeding women. 5. Current treatment with another investigational drug. 6. Any other medical history or condition that, in the investigator's judgment, makes the participant unsuitable for the study. \-
Contact & Investigator
Lei Zhang
STUDY DIRECTOR
Thrombosis and Haemostasis Diagnosis Treatment Center
Frequently Asked Questions
Who can join the NCT07788456 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying ITP - 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 NCT07788456 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07788456 currently recruiting?
Yes, NCT07788456 is actively recruiting participants. Contact the research team at liuxiaofan@ihcams.ac.cn for enrollment information.
Where is the NCT07788456 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07788456 clinical trial?
NCT07788456 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Lei Zhang at Thrombosis and Haemostasis Diagnosis Treatment Center. The trial plans to enroll 38 participants.