NCT07597395尚未招募3 期
All-trans Retinoic Acid for Management of Primary Immune Thrombocytopenia : a Randomized, Double-blind, Placebo-controlled Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 192
- 试验地点
- 1
研究概览
简要总结
A multicenter, randomized, double-blind placebo-controlled study to report the efficacy and safety of all-trans etinoic acid compared to placebo for the treatment of adults with corticosteriod-resistant/relapsed primary immune thrombocytopenia (ITP).
详细描述
The investigators are undertaking a parallel-group, multicenter, randomized controlled trial of 192 adults with corticosteriod-resistant/relapsed primary ITP. Patients were randomized to all-trans etinoic acid and placebo group. Platelet count, bleeding, and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary ITP if aged ⩾18 years;
- •With an average of two platelet counts ⩾1 day apart of <30×10^9/L during screening and no single platelet count >35×10^9/L within 2 weeks before study treatment;
- •Patients who have previously received at least one first-line standard therapy for ITP (corticosteroid and/or intravenous immunoglobulin) with unsustained efficacy, relapse, intolerance to standard therapy, or insufficient response.
排除标准
- •Pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant;
- •With active malignancy or a history of malignant tumor;
- •Having experienced severe bacterial, viral, fungal or parasitic infection within the past 4 weeks;
- •With a history of symptomatic herpes zoster infection within 12 weeks prior to screening;
- •Active or chronic HBV, HCV or HIV infection;
- •Evidence of active tuberculosis; or previous evidence of active tuberculosis without appropriate and documented treatment; or household contact with patients with active tuberculosis without appropriate and documented tuberculosis prophylaxis;
- •Receipt of live vaccines within the past 12 weeks, or planned live vaccination during the study period;
- •Prior ATRA therapy;
- •History of solid organ transplant or planned surgery;
- •Myelodysplastic syndrome, aplastic anemia or myelofibrosis;
- •Patients with other diseases were undergoing treatment with immunosuppressants;
- •Clinically significant thromboembolic events within the past 24 weeks, or ongoing anticoagulant treatment, who are deemed ineligible for the study by the investigator;
- •History or presence of myocardial infarction, unstable ischemic heart disease, stroke, or NYHA Class IV heart failure;
- •History or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, neuropsychiatric or any other severe and/or unstable diseases that, in the opinion of the investigator, may pose an unacceptable risk with the investigational product or interfere with the interpretation of study data;
- •AST > 2 times the upper limit of normal (ULN), ALT > 2×ULN, TBIL ≥ 1.5×ULN;
- •WBC < 2500/µL, neutrophil count < 1200/µL, lymphocyte count < 750/µL, hemoglobin < 9 g/dL;
- •eGFR < 50 mL/min/1.73m²;
- •Other patients deemed unsuitable for enrollment in this study by the investigator.
研究组 & 干预措施
ATRA
Experimental
ATRA 10mg twice daily
干预措施: all-trans retinoic acid (ATRA) (Drug)
Placebo
Placebo Comparator
Placebo 10mg twice daily
干预措施: Placebo (Drug)
研究者
Xiao Hui Zhang
Vice president of Peking University Institute of Hematology
Peking University People's Hospital
研究点 (1)
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