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| Name | Class |
|---|---|
| Peking University Health Science Center | OTHER |
| Cisen Pharmaceutical CO., LTD. | INDUSTRY |
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A multicenter, open-label, randomized study to report the efficacy and safety of teriflunomide plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with newly diagnosed primary immune thrombocytopenia (ITP).
The investigators are undertaking a parallel-group, multicenter, randomized controlled trial of 132 adults with ITP in China. Patients were randomized to teriflunomide plus high-dose dexamethasone and high-dose dexamethasone 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 |
|---|---|---|---|
| Teriflunomide plus Dexamethasone | Experimental | Oral Teriflunomide was given at a dose of 14 mg once daily for 24 weeks, and dexamethasone was given at a dose of 40mg orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10^9/L or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment. |
|
| Dexamethasone | Active Comparator | Dexamethasone was given at a dose of 40mg, orally once per day for 4 consecutive days (Days 1, 2, 3, and 4). Nonresponsive participants with platelets less than 30 x10^9/L or with active bleeding were allowed to repeat the 4-day course of dexamethasone treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriflunomide | Drug | Teriflunomide 14 mg orally once daily for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained response | Sustained response was defined as a platelet count ≥ 30 x10^9/L and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy for at least three of the four visits of the last 8 weeks of treatment. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Initial response | The number of participants with achievement of CR or R at 4 weeks. Complete response (CR) was defined as a platelet count ≥ 100 x10^9/L and absence of bleeding. Response (R) was defined as a platelet count ≥ 30 x10^9/L and at least a 2-fold increase of the baseline count and absence of bleeding. No response was defined as a platelet count of less than 30 x10^9/L, or less than two times increase from baseline platelet count, or bleeding. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao-Hui Zhang, MD | Contact | +8613522338836 | zhangxh@bjmu.edu.cn | |
| Li-Ping Yang, MD | Contact | +8618519172033 | lpyang@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiao-Hui Zhang, MD | Peking University Institute of Hematology, Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| Dexamethasone | Drug | Dexamethasone 40 mg orally once daily for four consecutive days. |
|
| Week 4 |
| Time to response | The time from treatment initiation to time of achievement of CR or R. | Week 24 |
| Duration of response | The time from the achievement of a CR or R to the loss of CR or R. | Week 24 |
| Bleeding events | Clinically significant bleeding was assessed using the World Health Organization (WHO) bleeding scale. | Week 24 |
| Adverse events | Adverse events (AEs) were reported and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. | Week 24 |
| Health-related quality of life (HRQoL) | ITP-patient assessment questionnaire (ITP-PAQ) was used to assess the HRQoL before and after treatment. | Week 24 |
| Peking University Insititute of Hematology, Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | 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 |
|---|---|
| C527525 | teriflunomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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