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NCT05369377 | Not yet recruiting | Immune Thrombocytopenia

Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary 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 eltrombopag compared to eltrombopag monotherapy for the first-line treatment of adults with chronic immune thrombocytopenia (ITP).

Condition or disease

Immune Thrombocytopenia

Intervention/treatment

Zanubrutinib

Eltrombopag

Phase

Phase 2

Detailed Description:

The investigators are undertaking a prospective trial of patients with ITP in China. Zanubrutinib is administered as 80 mg po. qd for 6 weeks. Eltrombopag is given with 50 mg once daily for up to 6 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. This study assessed the efficacy and safety of eltrombopag plus zanubrutinib.}}

Study Type : Interventional
Estimated Enrollment : 150 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Zanubrutinib and Eltrombopag as Second-line Treatment for Patients With Immune Thrombocytopenia: a Multicentre, Open-label,Randomised, Controlled, Phase 2 Trial
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : December 30, 2025
Arm Intervention/treatment

Experimental: Zanubrutinib and eltrombopag

Zanubrutinib 80mg po qd 6 weeks and eltrombopag 50 mg qd for up to 6 weeks.

Drug: Zanubrutinib

Active Comparator: Eltrombopag monotherapy

Eltrombopag is given as 50 mg qd for up to 6 weeks.

Drug: Eltrombopag
Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
  • Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have failed at least one treatment for chronic low platelet count
  • 2. Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation 3. Willing and able to sign written informed consent
Exclusion Criteria
  • Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
  • congestive heart failure
  • severe arrhythmia
  • nursing or pregnant women
  • aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
  • creatinine or serum bilirubin levels each 1•5 times or more than the normal range
  • active or previous malignancy
  • Unable to do blood routine test for the sake of time, distance, economic issues or other reasons
  • History of clotting disorder
Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia

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Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia

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Locations

Not yet recruiting

China, Beijing

Peking University Institute of Hematology, Peking University People's Hospital

Beijing, Beijing, China, 100010