Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Hospital | OTHER_GOV |
| Navy General Hospital, Beijing | OTHER |
| Beijing Aerospace General Hospital | OTHER |
| Qilu Hospital of Shandong University |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zanubrutinib and eltrombopag | Experimental | Zanubrutinib 80mg po qd 6 weeks and eltrombopag 50 mg qd for up to 6 weeks. |
|
| Eltrombopag monotherapy | Active Comparator | Eltrombopag is given as 50 mg qd for up to 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | Zanubrutinib 80mg po qd 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response | The proportion of patients who had an increase in platelet counts to 50 000 per μL or more after 6 weeks of treatment | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response | The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication after 6 weeks of treatment | 6 weeks |
| Complete response (CR) |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohui Zhang, MD | Contact | +8613522338836 | zhangxh100@sina.com | |
| Qiusha Huang, MD | Contact | +8613051816058 | huangfuqs@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohui Zhang, md | Peking University People's Hospital, Peking University Insititute of Hematology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Insititute of Hematology, Peking University People's Hospital | Beijing | Beijing Municipality | 100010 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| C520809 | eltrombopag |
Not provided
Not provided
Not provided
| OTHER |
| Beijing Tongren Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Eltrombopag | Drug | eltrombopag 50 mg qd for up to 6 weeks. The eltrombopag dose could be increased from 50 mg to 75 mg after 3 weeks in patients whose platelet counts were less than 50 000 per μL. Treatment was discontinued in patients who attained a platelet count greater than 200 000 per μL. |
|
Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding
| 6 weeks |
| Time to response | The time from starting treatment to time of achievement of Response | 6 weeks |
| Sustained response | The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 12-month follow-up | 12 month |
| Number of patients with bleeding | Number of patients with bleeding complication ( WHO bleeding score) | 12 months |
| Number of patients with adverse events | Number of patients with adverse events | 12 months |
| Duration of response (DOR) | Duration of response at 12-month follow up | 12 months |
| Loss of response | Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R) | 12 months |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |