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| Name | Class |
|---|---|
| The Second Hospital of Hebei Medical University | OTHER |
| Xijing Hospital | OTHER |
| The Affiliated Hospital of Inner Mongolia Medical University | OTHER |
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TE-ITP study: Compare the efficacy and safety of optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia patients.
A multicenter randomized open-label trial to compare the efficacy and safety of an optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia. Total treatment duration is 6 weeks, the primary endpoint is "median time to achieve platelet count ≥50x10^9/L during 6 weeks observation".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized rhTPO treatment | Experimental | The study in a 2:1 randomization ratio (117 subjects to rhTPO group). |
|
| Eltrombopag treatment | Active Comparator | The study in a 2:1 randomization ratio (58 subjects to Eltrombopag group). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhTPO | Drug | initial therapy: rhTPO s.c, 300 or 600U/kg daily based on baseline platelet count; maintenance therapy: rhTPO s.c, 300 ~ 600U/kg every other day depends on platelet count. |
| Measure | Description | Time Frame |
|---|---|---|
| Median time to achieve platelet count ≥50x10^9/L during 6 weeks observation | Time from the start of treatment to the first time of achieving a platelet count ≥50x10^9/L without salvage therapy during the first 6 weeks. | in 6 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Early response | Early response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 1 week. | after 1 week treatment |
| Initial response | Initial response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 1 month. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lei Zhang, MD | Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530007 | China | ||
| the Second Hospital of HeBei Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40896456 | Derived | Chen Y, Sun T, Gao D, Wang W, Zhou Z, Gao G, Wang Y, Zhou H, Song Y, Lai Y, Yan Z, Yan J, Bai J, Zhang L. Dose-optimised recombinant human thrombopoietin versus eltrombopag in patients with immune thrombocytopenia: a multicenter, randomised controlled trial (The TE-ITP Study). EClinicalMedicine. 2025 Aug 21;87:103459. doi: 10.1016/j.eclinm.2025.103459. eCollection 2025 Sep. |
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Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.
From 12 months 36 months after study completion.
Upon request to PI.
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| The Second Affiliated Hospital of Kunming Medical University |
| OTHER |
| Second Affiliated Hospital of Guangzhou Medical University | OTHER |
| Shaanxi Provincial People's Hospital | OTHER |
| Henan Cancer Hospital | OTHER_GOV |
| North China University of Science and Technology | OTHER |
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
| Second Hospital of Shanxi Medical University | OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| Shenyang Sunshine Pharmaceutical Co., LTD. | INDUSTRY |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| People's Hospital of Xinjiang Uygur Autonomous Region | OTHER |
| Kashgar 1st People's Hospital | OTHER |
| Xi'an Central Hospital | OTHER |
| Beijing Public Health Foundation | UNKNOWN |
| Yuyao People's Hospital | OTHER |
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|
| Eltrombopag | Drug | initial therapy: Eltrombopag oral, 25 or 50mg daily based on baseline platelet count; maintenance therapy: Eltrombopag oral, 25 ~ 75mg daily or every other day depends on platelet count. |
|
|
| after 1 month treatment |
| 6 weeks response | 6 weeks response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 6 weeks. | after 6 weeks treatment |
| 4 months response | 4 months response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 3 months. | after 4 months treatment |
| Durable response | Durable response is defined as platelet count ≥ 30×10^9/L and at least doubling baseline at 6 months. | after 6 months treatment |
| Time to treatment failure | Treatment failure is defined as:
| in 6 weeks treatment |
| Incidence of adverse events | treatment-related adverse events. | from study start date to the end of follow-up, up to 6 months |
| Number of subjects with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0 | Number of subjects with dosage under 600U/kg of rhTPO adverse events as assessed by CTCAE v5.0 | from study start date to the end of follow-up, up to 6 months |
| Number of subjects who develop anti-rhTPO antibodies | Number of subjects who develop anti-rhTPO antibodies | from study start date to the end of follow-up, up to 6 months |
| The duration time with platelet count ≥50x10^9/L | Total duration of time a subject had platelet count ≥50x10^9/L during treatment | in 6 weeks treatment |
| Shijiazhuang |
| Hebei |
| 050000 |
| China |
| North China University of Science and Technology Affiliated Hospital | Tangshan | Heibei | 063000 | China |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150000 | China |
| Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | 010107 | China |
| The Second Hospital of Dalian Medical University | Dalian | Liaoning | 116000 | China |
| Xi'an Central Hospital | Xi'an | Shaanxi | 710032 | China |
| Xijing Hospital of the Fourth Military Medical University | Xi'an | Shaanxi | 710032 | China |
| Shaanxi Provincial People's Hospital | Xi'an | Shaanxi | 710068 | China |
| Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC | Tianjin | Tianjin Municipality | 300020 | China |
| The Second Hospital of Tianjin Medical University | Tianjin | Tianjin Municipality | 300211 | China |
| Kashgar District 1st People's Hospital | Kashgar | Xinjiang | 844000 | China |
| People's Hospital of Xinjiang Uygur Autonomous Region | Ürümqi | Xinjiang | 830001 | China |
| The first affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830011 | China |
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650101 | China |
| Yuyao People's Hospital of Zhejiang Province | Yuyao | Zhejiang | 315400 | China |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| 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 |
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| ID | Term |
|---|---|
| D013926 | Thrombopoietin |
| C520809 | eltrombopag |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| 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 |
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