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| Name | Class |
|---|---|
| Beijing Friendship Hospital | OTHER |
| Beijing Tongren Hospital | OTHER |
| Beijing Hospital | OTHER_GOV |
| Navy General Hospital, Beijing |
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A Prospective, Randomized, Open-Label, Multicenter Clinical Trial study to compare the efficacy and safety of ATRA plus eltrombopag compared to eltrombopag monotherapy in the treatment of steroid-resistant/relapsed immune thrombocytopenia (ITP).
The investigators are undertaking a parallel group, multicenter, randomized controlled trial of patients with ITP in China. Patients were tested for MSCs, and they were divided into MSC-C5b-9+ group and MSC-C5b-9- group according to the test results, and the two groups were randomized to ATRA + eltrombopag and eltrombopag monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eltrombopag | Active Comparator | The initial dose of eltrombopag was 50 mg/time, once a day. According to the clinical standard of eltrombopag dose adjustment in the research protocol set by the research group, the dose was increased when the platelet count was lower than 5×109/L. The highest is 75mg/d, if the dose is higher than 200×109/L, the dose is reduced. When the dose is higher than 400×109/L, the drug is temporarily discontinued, and the drug is repeated according to the platelet count. The treatment course is 12 weeks. |
|
| ATRA and Eltrombopag | Experimental | ATRA 10 mg, 2 times a day, orally; The initial dose of eltrombopag was 50 mg/time, once a day. According to the clinical standard of eltrombopag dose adjustment in the research protocol set by the research group, the dose was increased when the platelet count was lower than 5×109/L. The maximum dose is 75 mg/d, the dose is reduced if it is higher than 200×109/L, and the drug is temporarily discontinued when it is higher than 400×109/L, and the drug is repeated according to the platelet count. The treatment course is 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| all-trans retinoic acid | Drug | ATRA 10 mg, 2 times a day, orally.The treatment course is 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Response Rate (SR) at 18 months | 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 18-month follow-up | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CR) | The complete response (CR) was defined as platelet count more than 100×10^9/L and absence of bleeding. | 18 months |
| Response rate (R) | The Response rate (R) was defined as platelet count more than 30×10^9/L and more than 2 times higher than baseline, without bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaohui Zhang, MD | Study Principal Investigator Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Insititute of Hematology, Peking University People's Hospital | Beijing | Beijing Municipality | 100010 | China | ||
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D014212 | Tretinoin |
| C520809 | eltrombopag |
| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 |
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| OTHER |
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| Eltrombopag | Drug | The initial dose of eltrombopag is 50 mg/time, once a day, and the dose is increased when the platelet count is lower than 5×109/L, the maximum is 75 mg/d, and the dose is higher than 200×109/L. When the drug is temporarily discontinued, the drug is re-administered according to the platelet count.The treatment course is 12 weeks. |
|
|
| 18 months |
| Inefficiency (NR) | Platelet count <30×10^9/L, or less than 2-fold increase from baseline or associated with bleeding | 18 months |
| Recurrence rate (relapse) | After the treatment is effective, the platelet count drops below 30×10^9/L or drops to less than 2 times the basal value, or bleeding symptoms occur | 18 months |
| Early response | Platelet count ≥30×10^9/L and at least doubling baseline at 1 wk. | 1 week |
| Initial response | Initial response as platelet count more than 30×10^9/L and at least 2-fold increase of the baseline count and absence of bleeding. | 1 month |
| Time to response (TTR) | The time from starting treatment to time of achievement of CR or R | 18 months |
| Time to relapse (duration of efficacy) | The time from achievement of CR or R to time of relapse | 18 months |
| Beijing Tongren hospital |
| Beijing |
| Beijing Municipality |
| China |
| Department of Hematology, Beijing Friendship Hospital, Capital Medical University | Beijing | China |
| Department of Hematology, Beijing Hospital | Beijing | China |
| Department of Hematology, Senior Department of Hematology, the Fifth Medical Center of PLA General Hospital | Beijing | China |
| 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 |
| Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |