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Trial withdrawn due to substantial protocol amendments invalidating the original design. With no participants enrolled, this aligns with WHO-ICTRP guidelines. Recruitment has ceased, and the revised protocol has been re-registered as NCT07065968.
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| Name | Class |
|---|---|
| Beijing Luhe Hospital | OTHER |
| Chinese PLA General Hospital | OTHER |
| Navy General Hospital, Beijing | OTHER |
| Beijing Hospital |
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A randomized, open-label, multicenter study to compare 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).
This is 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. Patients who do not respond to dexamethasone may receive another cycle of high-dose dexamethasone therapy within 2 weeks. 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 7 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 20 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). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than 20 x 10^9/L or with active bleeding were also allowed to repeat the 4-day course of dexamethasone treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriflunomide | Drug | Teriflunomide 7 mg orally once daily for 24 weeks. Dose adjustments were made throughout the study based on individual platelet counts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained response | Platelet count over 30,000/μL and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy for at least four of the six visits between weeks 19 and 24. | From the start of study treatment (Day 1) to the end of week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response | Complete response (CR) was defined as platelet count over 100,000/μL and absence of bleeding. Response (R) was defined as platelet count over 30,000/μL and at least a 2-fold increase of the baseline count and absence of bleeding. | From the start of study treatment (Day 1) to the end of week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Beijing | China | ||||
| Beijing Hospital |
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| OTHER_GOV |
| Beijing Friendship Hospital | OTHER |
| Peking University First Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| China-Japan Friendship Hospital | OTHER |
| Beijing Tsinghua Changgeng Hospital | OTHER |
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|
| Dexamethasone | Drug | Dexamethasone 40 mg orally once daily for four consecutive days (the 4-day course of dexamethasone was repeated in the case of lack of response by day 14). |
|
| Time to response |
The time from treatment initiation to achieve a CR or a R. |
| From the start of study treatment (Day 1) to the end of week 24 |
| Duration of response | The time from the achievement of a complete response or a partial response to the loss of response. | From the start of study treatment (Day 1) to the end of week 24 |
| Initial response | The number of participants with achievement of CR or R at 4 weeks. | From the start of study treatment (Day 1) up to week 4 of treatment |
| Bleeding events | Clinically significant bleeding was assessed using the World Health Organization (WHO) bleeding scale. | From the start of study treatment (Day 1) to the end of week 24 |
| Adverse events | Adverse events (AEs) were reported and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. | From the start of study treatment (Day 1) to the end of follow-up |
| Health-related quality of life (HRQoL) | ITP-patient assessment questionnaire (ITP-PAQ) was used to assess the HRQoL before and after treatment. | From the start of study treatment (Day 1) to the end of week 24 |
| Beijing |
| China |
| Beijing Luhe Hospital | Beijing | China |
| Beijing Tsinghua Changgeng Hospital | Beijing | China |
| China-Japan Friendship Hospital | Beijing | China |
| Chinese PLA General Hospital | Beijing | China |
| Peking University First Hospital | Beijing | China |
| Peking University Insititute of Hematology, Peking University People's Hospital | Beijing | China |
| Peking University Third Hospital | Beijing | China |
| The Sixth Medical Center of PLA General Hospital | Beijing | 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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