NCT07266155尚未招募2 期
A Phase Ⅱ Extension Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Longbio Pharma1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月5日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This is an extension study for patients who have completed a prior P10-LP005-02 clinical study. The aim of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of LP-005 injection in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have fully understood the trial, have voluntarily agreed to participate in this clinical trial, and have signed a written Informed Consent Form (ICF).
- •Patients who have completed the treatment of the Phase Ⅱ clinical study of LP-005 Injection and are assessed by the investigator as eligible for continued treatment with LP-005 Injection.
- •Patients who have received Neisseria meningitidis vaccine and Streptococcus pneumoniae vaccine in accordance with the requirements of previous studies; if the vaccine protection period does not cover the treatment duration of this study, patients must agree to receive booster vaccination in a timely manner in accordance with the vaccine administration guidelines and the requirements of local vaccination institutions.
- •Females and males of childbearing potential (including male subjects with female partners) must agree to use effective contraceptive measures from the start of the trial until 3 months after the end of the trial.
排除标准
- •Patients who have not completed the treatment of the Phase II clinical trial (P10-LP005-02) of the study drug.
- •Patients who have completed the Phase II treatment phase but are unwilling to continue receiving the study drug treatment.
- •Patients for whom the investigator does not recommend the continued use of LP-005 Injection after comprehensive assessment.
- •Patients who did not participate in the Phase II clinical trial (P10-LP005-02) of the study drug.
研究组 & 干预措施
LP-005 1200 mg
Experimental
Patients will receive intravenous infusion of LP-005 Injection at a dose of 1200 mg once every 4 weeks.
干预措施: LP-005 Injection (Biological)
LP-005 1500 mg
Experimental
Patients will receive intravenous infusion of LP-005 Injection at a dose of 1500 mg once every 4 weeks.
干预措施: LP-005 Injection (Biological)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Up to approximately 2 years
次要结局
- Change from baseline in serum lactate dehydrogenase (LDH) levels.(Up to approximately 2 years)
- Proportion of patients achieving hemoglobin levels ≥120 g/L(Up to approximately 2 years)
- Proportion of patients with breakthrough hemolysis(Up to approximately 2 years)
- Serum concentrations of LP-005.(Up to approximately 2 years)
- Number of patients with anti-drug antibodies (ADA)(Up to approximately 2 years)
- Change from baseline in hemoglobin levels.(Up to approximately 2 years)
- Proportion of patients who are transfusion-free.(Up to approximately 2 years)
研究者
研究点 (1)
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