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The purpose of this study is to explore the multiple-dose regimen of recombinant human thrombopoietin (rhTPO) injection for the treatment of thrombocytopenia in patients with chronic liver disease.
This is a multi-center, open label, phase Ib clinical study. The effectiveness of the multiple-dose regimen of recombinant human thrombopoietin injection in the treatment of thrombocytopenia in patients with chronic liver disease is mainly verified by evaluating the proportion of responders with platelet count in the first 8 days after treatment. Cohort 1 (n=18) : 50*10^9/L ≤ Baseline of PLT < 75*10^9/L. Cohort 2 (n=36) : 30*10^9/L ≤ Baseline of PLT < 50*10^9/L.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 : 50*10^9/L ≤ Baseline of PLT < 75*10^9/L | Experimental | The multiple-dose regimen (15000 U subcutaneous injection once a day for 7 days) of recombinant human thrombopoietin (rhTPO) injection for the treatment of thrombocytopenia in patients with chronic liver disease. |
|
| Cohort 2 : 30*10^9/L ≤ Baseline of PLT < 50*10^9/L. | Experimental | The multiple-dose regimen (15000 U subcutaneous injection once a day for 7 days) of recombinant human thrombopoietin (rhTPO) injection for the treatment of thrombocytopenia in patients with chronic liver disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human thrombopoietin injection | Drug | recombinant human thrombopoietin: 15000 U subcutaneous injection once a day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of responders with platelet count | Based on the results of routine blood tests, calculate the proportion of responders with platelet counts in the first 8 days after treatment | Up to 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of responders with platelet count | Based on the results of routine blood tests, calculate the proportion of responders with platelet counts during the study | Up to 36 days |
| Platelet count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Tong, MD | Contact | 021-60970099 | tonggang@3sbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Yimin Cui, PhD | Peking University First Hospital | Principal Investigator |
| Xiaoyuan Lin, Master | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D013926 | Thrombopoietin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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Based on the results of routine blood tests, calculate the change in platelet count from baseline at different visit times after treatment. Calculate the duration of alleviation of thrombocytopenia symptom relief to different levels (≥50×10^9/L; ≥75×10^9/L; ≥100×10^9/L).
| Up to 36 days |
| Platelet peak | Based on the results of routine blood tests, observe the peak value of platelets and record the peak time after treatment. | Up to 36 days |
| AE | All adverse events related to rhTPO observed through various tests (including blood routine, liver function, pregnancy test, electrocardiogram, etc.) | Up to 36 days |
| Immunogenicity of rhTPO | Detect the presence of anti-rhTPO antibodies through the subject's blood sample | At Day 1, Day 14, Day 36 |
| Cmax | Detect the blood concentration of rhTPO by the subject's blood sample | Up to 36 days |
| AUC | Detect the blood concentration of rhTPO by the subject's blood sample, then calculate the area under the curve (AUC) | Up to 36 days |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |