Immune Thrombocytopenic Purpura (ITP) Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age ≥18 years.

• Confirmed newly diagnosed primary ITP with a platelet count \<30 × 10\^9/L.

• No prior ITP-related treatment before enrollment, except for standard-dose corticosteroids and/or IVIG for ≤5 days.

• Able to understand the study and provide signed informed consent.-

Locations
Other Locations
China
Ethics Committee of Hematology Hospital, Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Contact Information
Primary
Xiaofan Liu
liuxiaofan@ihcams.ac.cn
+86-022-23608180
Backup
Rongfeng Fu
furongfeng@ihcams.ac.cn
Time Frame
Start Date: 2026-06-22
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 38
Treatments
Experimental: Initial therapy
standard-dose corticosteroids plus a thrombopoietin receptor agonist (TPO-RA)
Experimental: Sequential Combination Therapy
the ongoing TPO-RA in combination with either rituximab or an anti-CD38 monoclonal antibody(mAb)
Experimental: Exploratory treatment
a switched TPO-RA combined with either rituximab or anti-CD38 monoclonal antibody
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov

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