Clinical Trials Logo

Clinical Trial Summary

To evaluate the safety and efficacy of zanubrutinib in the treatment of immune thrombocytopenia in 30 patients.


Clinical Trial Description

Immune thrombocytopenia (ITP) is an organ-specific autoimmune disease, which is characterized by decreased platelet count and skin and mucosal bleeding. ITP is a kind of disease with increased platelet destruction and impaired platelet production caused by autoimmunity. Conventional treatment of adult ITP includes first-line glucocorticoid and immunoglobulin therapy, second-line TPO and TPO receptor agonist, splenectomy and other immunosuppressive treatments (such as rituximab, vincristine, azathioprine, etc.). ITP is one of the most common hemorrhagic diseases. At present, the treatment response of ITP is not good, and a considerable number of patients need drug maintenance treatment, which seriously affects the quality of life of patients and increases the economic burden of patients. Therefore, there is still a lack of effective treatment for adult ITP, especially for refractory ITP patients, which is one of the problems that have attracted more attention and need to be solved urgently. BTK inhibitors can affect autoimmune diseases (AID) involving B cells and non-B cells through B cell receptor, Fc receptor and RANK receptor signals, such as systemic lupus erythematosus (SLE), multiple sclerosis (MS) and rheumatoid arthritis (RA) .Therefore, small molecule BTK inhibitors can treat autoimmune diseases by targeting B cells. At present, clinical studies on the treatment of immune thrombocytopenia with BTK inhibitor (BRN1008) have been carried out abroad. The preliminary results show that 50% of patients in the treatment ≥ 12 weeks and the initial dose is 400 mg BID group have reached the primary endpoint and maintained platelet response. Zebutinib is a new selective Bruton tyrosine kinase (BTK) inhibitor developed by Baekje Shenzhou Company of China. In November 2019, it was approved by the US Food and Drug Administration to treat adult mantle cell lymphoma (MCL) patients who had received at least one treatment before. Compared with the first generation BTK inhibitors (ibutinib and acalabrutinib), zebutinib has stronger targeting and fewer adverse reactions. Therefore, the investigators designed this clinical trial to provide new treatment options for clinical treatment of ITP. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05214391
Study type Interventional
Source Institute of Hematology & Blood Diseases Hospital
Contact Yunfei Chen
Phone +8618502220788
Email chenyunfei@ihcams.ac.cn
Status Recruiting
Phase Phase 2
Start date February 15, 2022
Completion date June 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT02287649 - Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP) N/A
Terminated NCT02401061 - PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP Phase 1/Phase 2
Completed NCT02556814 - Caffeic Acid Combining High-dose Dexamethasone in Management of ITP Phase 4
Completed NCT02868099 - Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP) Phase 3
Completed NCT02351622 - Caffeic Acid Tablets as a Second-line Therapy for ITP Phase 3
Active, not recruiting NCT04741139 - Post IVIG Medication in Children With Immune Thrombocytopenia Phase 1
Not yet recruiting NCT05494307 - The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia Phase 2
Not yet recruiting NCT05468866 - The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia N/A
Recruiting NCT04993885 - Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies Phase 2
Recruiting NCT05281068 - The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia Phase 2
Not yet recruiting NCT05020288 - A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP Phase 2
Withdrawn NCT03965624 - Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia Phase 2
Not yet recruiting NCT03252457 - Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP Phase 3
Recruiting NCT05937828 - OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
Completed NCT03156452 - Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate Phase 3
Completed NCT03164915 - A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP) Phase 3
Recruiting NCT02270801 - Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy Phase 3
Completed NCT01933035 - Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias. N/A
Withdrawn NCT01976195 - High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP Phase 2
Recruiting NCT02821572 - Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)