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NCT05369364 | Not yet recruiting | Immune Thrombocytopenia

The Combination of Zanubrutinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia
Sponsor:

Peking University People's Hospital

Information provided by (Responsible Party):

ξAO Hui Zhang

Brief Summary:

Randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

Condition or disease

Immune Thrombocytopenia

Intervention/treatment

Zanubrutinib

Dexamethasone

Phase

Phase 2

Detailed Description:

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of patients with ITP in China. Patients were randomized to Zanubrutinib + high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.}}

Study Type : Interventional
Estimated Enrollment : 150 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : The Combination of Oral Zanubrutinib and High-dose Dexamethasone vs High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia: A Multicenter, Randomized, Open-label Trial
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : June 1, 2026
Arm Intervention/treatment

Experimental: Zanubrutinib and HD-DXM

Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 10) and Zanubrutinib 80mg qd po, 6 consecutive weeks

Drug: Zanubrutinib

Active Comparator: HD-DXM

Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 10)

Drug: Dexamethasone
Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Confirmed newly-diagnosed, treatment-naive ITP;
  • Platelet counts <30×10^9/L ;
  • Platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
  • Willing and able to sign written informed consent.
Exclusion Criteria
  • Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
  • Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
  • Current HIV infection or hepatitis B virus or hepatitis C virus infections;
  • Active infection;
  • Maligancy;
  • Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);
  • Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy;
  • Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
The Combination of Zanubrutinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

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The Combination of Zanubrutinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

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