NCT07575308招募中2 期
HMBeacon: A Phase 2, Randomized, Double-blind Study of the Safety, Tolerability, Efficacy, and Pharmacodynamics of Multiple Dose ALN-6400 in Adult and Adolescent Female Patients With Von Willebrand Disease (VWD) and Heavy Menstrual Bleeding (HMB)
Alnylam Pharmaceuticals13 个研究点 分布在 4 个国家目标入组 24 人开始时间: 2026年7月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 13
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacodynamics (PD) of multiple doses of ALN-6400 in adult and adolescent patients with VWD and HMB
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
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Is an adolescent or adult patient with a diagnosis of VWD (including Type 1, Type 2, Type 3, and platelet-type VWD) and HMB for 2 cycles during screening
排除标准
- •Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times the upper limit of normal (ULN)
- •Has total bilirubin greater than 1.5×ULN (except for patients with Gilbert's syndrome)
- •Has an estimated glomerular filtration (eGFR) less than 30 mL/min/1.73m^2 at screening
- •Is not willing to comply with the contraceptive requirements during the study period
- •Used routine factor prophylaxis (greater than or equal to 1 infusion of factor per week over 12 weeks) within 4 weeks of screening or plans use for routine factor prophylaxis during the study
- •New placement of any hormonal or nonhormonal intrauterine device (IUD) or hormonal implants within 24 weeks of screening
- •Known current gynecological conditions causing abnormal uterine bleeding (including infection, fibroids, endometriosis, polycystic ovary syndrome, or dysplasia)
- •Note: other protocol defined inclusion / exclusion criteria apply
研究组 & 干预措施
ALN-6400 (Treatment Group B)
Experimental
Participants will be administered multiple doses of ALN-6400.
干预措施: ALN-6400 (Drug)
ALN-6400 (Treatment Group A)
Experimental
Participants will be administered multiple doses of ALN-6400.
干预措施: ALN-6400 (Drug)
结局指标
主要结局
Frequency of Adverse Events
时间窗: Up to Week 72
次要结局
- Change from Baseline in Plasminogen (PLG) Plasma Activity Levels(Screening and up to Week 72 postdose)
- Change from Baseline in PLG Plasma Protein Levels(Screening and up to Week 72 postdose)
- Change from Baseline in Menstrual Blood Loss Via Pictorial Blood Assessment Chart (PBAC)(Screening and up to Week 72 postdose)
- Patient-reported Outcome (PRO) assessed by Patient Global Impression of Change (PGI-C) Score(Week 4 up to Week 72)
- Change from Baseline in PRO assessed by Patient Global Impression of Severity (PGI-S) Score(Baseline up to Week 72)
研究者
研究点 (13)
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