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The purpose of the study is to evaluate the efficacy and safety of avatrombopag for the promotion of platelet engraftment after Allo-HSCT.
Patients with thrombocytopenia (PLT<20×10^9/L) after allogenic hematopoietic stem cell transplantation (Allo-HSCT) who meet Eligibility Criteria were assigned into the avatrombopag group for 4 weeks' treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avatrombopag | Experimental | In the 4-weeks'study,the initial dose of avatrombopag is 20 mg/d. If the patient's PLT count remains less than 20*10^9/L after one week, the maximum dose was increased to 40 mg/d. Avatrombopag will be taken orally with food. |
|
| Supportive care | Other | Patients in this arm receive same treatment as in the avatrombopag group,except any TPO-RAs or recombinant human thrombopoietin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avatrombopag | Drug | Avatrombopag administered at the described frequency to achieve a target platelet count |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants whose PLT reaches ≥ 20*10^9/L without the need for PLT transfusion. | Accumulated platelet engraftment ratio | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants whose PLT reaches ≥ 50*10^9/L without the need for PLT transfusion. | Accumulated complete platelet engraftment ratio | up to 4 weeks |
| The time to achieve PLT ≥ 20*10^9/L without the need of PLT transfusion for consecutive 7 days (Defined as the first day when PLT ≥ 20×10^9/L without relying on platelet transfusion for 7 consecutive days ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue Han, MD PhD | Contact | (0086)51267781856 | hanyue@suda.edu.cn | |
| Depei Wu, MD PhD | Contact | (0086)51267781856 | drwudepei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yue Han | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36185780 | Background | Zhou M, Qi J, Gu C, Wang H, Zhang Z, Wu D, Han Y. Avatrombopag for the treatment of thrombocytopenia post hematopoietic stem-cell transplantation. Ther Adv Hematol. 2022 Sep 28;13:20406207221127532. doi: 10.1177/20406207221127532. eCollection 2022. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 28, 2021 | Nov 16, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C533238 | avatrombopag |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Patients will be randomized into avatrombopag group or supportive care group at the ratio of 1:1.
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| Supportive care | Other | Supportive care other than TPO-RAs or recombinant human thrombopoietin. |
|
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time duration of platelet engraftment |
| up to 4 weeks |
| Volume of PLT transfusion | Volume of PLT transfusion | up to 4 weeks |
| Hematopoietic reconstruction condition | absolute neutrophils, hemoglobin | up to 4 weeks |