Multi-target drugs sequentially combine therapy in adults with newly diagnosed immune thrombocytopenia
Official title: Efficacy and Safety of Multi-Target Drugs Sequential Combination Therapy in Adults Patients With Newly Diagnosed Primary Immune Thrombocytopenia: A Prospective, Single-arm, Multicenter, Exploratory Trial
Run by Institute of Hematology & Blood Diseases Hospital, China · NCT07788456 · Data updated 2026-11-12
This study tests whether starting with standard steroids plus a TPO-RA, then adding a second targeted therapy if needed, can improve platelet counts in adults with newly diagnosed ITP.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 38 (estimated) |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | rituximab, prednisone |
| Locations | 1 site (Tianjin) |
| Status | Recruiting |
| Started | June 22, 2026 |
| Main results expected | May 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | August 26, 2026 |
| Trial ID | NCT07788456 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with newly diagnosed primary ITP and a platelet count below 30 x 10^9/L, who have not received prior ITP-specific treatment besides limited corticosteroids or IVIG.
✕Probably not a fit
Patients with contraindications to corticosteroids or TPO-RA, thromboembolic events within 3 months, pregnancy, or those already on another investigational drug may not benefit and are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, single-arm, phase 4 trial enrolling about 38 adults with newly diagnosed primary ITP. All participants receive initial therapy with standard-dose corticosteroids plus a thrombopoietin receptor agonist for 12 weeks, with steroids tapered by 8 weeks. If responders do not achieve adequate platelet responses by week 2 of initial therapy, a sequential combination strategy with rituximab or an anti-CD38 monoclonal antibody is explored. The study includes a 24-week follow-up phase, with exploratory treatment adjustments for those with treatment failure, and dose adjustments of the TPO-RA as per labeling. Primary goals are to assess safety and feasibility of this sequential, multi-target approach in this setting.
Why it matters
Potential benefit: If successful, the approach could improve platelet recovery and potentially reduce bleeding risk in newly diagnosed ITP patients by using targeted therapy escalation.
How similar studies have gone: Prior studies in ITP have explored TPO-RA plus corticosteroids and sequential antibody therapy, showing mixed results; this trial adds a structured sequential combination phase.
Who can join: the full rules
Show full inclusion / exclusion 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. \-
Where it's running
-
Ethics Committee of Hematology Hospital, Chinese Academy of Medical Sciences
Tianjin, China Recruiting
Study contacts
- Study coordinator: Xiaofan Liu
- Email: liuxiaofan@ihcams.ac.cn
- Phone: +86-022-23608180
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.