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This multi-center study aims to study the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years. This study will be conducted in ITP patients who had not responded to first-line in the previous treatment .
The primary objective of this study was to evaluate the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years who had not responded to first-line in the previous treatment.
100 eligible subjects will be enroll ed in this study.The dose will be adjusted according to the subject platelet count during the period from week 1 to week 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 100 subjects will be enrolled with the indicated treatment dose of TPO-RA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPO-RA | Drug | The subjects will receive an initial dose of TPO-RA once daily. Platelet counts were collected weekly until week 6 of the study. Dosage was adjusted to maintain platelet levels between 50×10^9/L and 150×10^9/L according to platelet count. TPO-RA was administered once a day for 4 weeks. If the platelet count dose not reach 30×10^9/L, the treatment was stopped. If the platelet count is more than 400×10^9/L after taking TPO-RA once a day for 2 consecutive weeks, the treatment will be stopped. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response | Percentage of participants whose platelet count achieving response (R) within 6weeks. | From the start of study treatment (Day 1) up to the end of week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response | Percentage of participants achieving a platelet count >=50×10^9/L at week 1,2,3,4,5and 6 of treatment. | From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6. |
| Treatment response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Liu | Contact | +82223909240 | liuwei1@ihcams.ac.cn | |
| Lei Zhang | Contact | +82223909240 | zhanglei1@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lei Zhang | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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Percentage of participants achieving a platelet count >=100×10^9/L at week 1,2,3,4,5and 6 of treatment.
| From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6. |
| Duration of response | Percentage of participants whose platelet count achieving persistence response (R) within 6weeks(defined as the proportion of subjects with a platelet count of ≥30×109/L for at least 4 weeks of the 6-week treatment period without remedial therapy). | From the start of study treatment (Day 1) up to the end of week 6 |
| Concomitant medication | The percentage of patients with reduced concomitant medication, reduced bleeding and remedial treatment. | From the start of study treatment (Day 1) up to the end of week 6 |
| Adverse events | Incidence of adverse events. | From the start of study treatment (Day 1) up to the end of week 6 |