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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 May 2022
• Main ID: NCT05369377
• Date of registration: 06/05/2022
• Prospective Registration: Yes
• Primary sponsor: Peking University People's Hospital
• Public title: Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia
• Scientific title: Zanubrutinib and Eltrombopag as Second-line Treatment for Patients With Immune Thrombocytopenia: a Multicentre, Open-label,Randomised, Controlled, Phase 2 Trial
• Date of first enrolment: June 1, 2022
• Target sample size: 150
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT05369377
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Xiaohui Zhang, md
• Affiliation: Peking University People's Hospital, Peking University Insititute of Hematology

• Name: Xiaohui Zhang, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes
of thrombocytopenia;

2. 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:

1. Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori
infection or patients with systemic lupus erythematosus)

2. congestive heart failure

3. severe arrhythmia

4. nursing or pregnant women

5. aspartate aminotransferase and alanine transaminase levels = 3× the upper limit of the
normal threshold criteria

6. creatinine or serum bilirubin levels each 1•5 times or more than the normal range

7. active or previous malignancy

8. Unable to do blood routine test for the sake of time, distance, economic issues or
other reasons

9. History of clotting disorder



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Immune Thrombocytopenia

Intervention(s)

Drug: Zanubrutinib

Drug: Eltrombopag

Primary Outcome(s)

Treatment response [Time Frame: 6 weeks]

Secondary Outcome(s)

Overall response [Time Frame: 6 weeks]

Complete response (CR) [Time Frame: 6 weeks]

Duration of response (DOR) [Time Frame: 12 months]

Loss of response [Time Frame: 12 months]

Number of patients with adverse events [Time Frame: 12 months]

Sustained response [Time Frame: 12 month]

Number of patients with bleeding [Time Frame: 12 months]

Time to response [Time Frame: 6 weeks]

Secondary ID(s)

Zan-Eltro-ITP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Beijing Aerospace General Hospital

Beijing Hospital

The Sixth Medical Center of PLA General Hospital

Beijing Tongren Hospital

Qilu Hospital of Shandong University