NCT05621330已完成3 期
Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- proportion of patients achieving durable platelet response at week 24 during the double-blind treatment period
研究概览
简要总结
QL0911, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein for injection, is a romiplostim (Nplate®) biosimilar for the treatment of primary immune thrombocytopenia (ITP). This phase III study aimed to assess the efficacy and safety of QL0911 in adult patients with primary chronic ITP.
详细描述
This study consisted of a randomized, double-blind, placebo-controlled, 26-week treatment period, sequentially followed by an open-label, single-arm, 12-week treatment period, and an additional 4-week safety follow-up period.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Aged ≥18 years old;
- •Diagnosed primary ITP for at least 12 months;
- •Had received at least one first-line ITP treatment with no response or recurrence after treatment;
- •Had a platelet count <30×10^9/L within 48 hours before the first dose;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
- •Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.
排除标准
- •Had a history of bone marrow stem cell abnormalities or myelodysplastic syndrome other than ITP-specific changes.
- •Had arterial thrombosis, or venous thromboembolism; severe cardiovascular diseases; malignant tumors; secondary thrombocytopenia caused by autoimmune diseases.
- •Underwent splenectomy within 12 weeks before the first dose;
- •Had received ITP treatments (including rescue treatment) within 2 weeks before the first dose;
- •Had received romiplostim (Nplate®) or eltrombopag (Revolade®), rhTPO or other agents that stimulate TPO receptors (also known as c-Mpl), and hematopoietic growth factors (HGFs) within 4 weeks before the first dose;
- •Had received antineoplastic agents within 8 weeks before the first administration, but when treating ITP with hypomethylating agents (HMA) such as decitabine, a 4-week washout period was acceptable, as judged by the investigator;
- •Had received antibody-based therapies within 14 weeks before the first dose; 8) had serum creatinine or total bilirubin >1.5 upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) >3 ULN, hemoglobin < 100g/L, absolute neutrophil count <1.5x10^9/L;
- •Had prothrombin time (PT) or prothrombin time-international normalized ratio (PT-INR) or activated partial thromboplastin time (APTT) exceeded 20% of the reference range of normal values.
研究组 & 干预措施
QL0911
Experimental
干预措施: QL0911 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo comparator (Drug)
结局指标
主要结局
proportion of patients achieving durable platelet response at week 24 during the double-blind treatment period
时间窗: 24weeks
次要结局
- proportion of patients with weekly platelet responses within 24 weeks of treatment;(24weeks)
- Proportion of patients who achieved platelet count ≥ 30 × 10^9/L at least a two-fold increase from baseline platelet count without bleeding during the 24-week double-blind period;(24weeks)
研究者
研究点 (1)
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