NCT07347249招募中2 期
A Clinical Study to Assess the Safety and Efficacy of Sutacimig in Participants With Congenital Factor VII Deficiency
Hemab ApS1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年3月11日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
Open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of sutacimig monotherapy in participants with congenital FVII deficiency (FVIID).
详细描述
The objective is to administer a single dose of sutacimig and to evaluate safety, pharmacokinetics, and pharmacodynamics. Two cohorts may be evaluated. Cohort A is defined by participants with a FVII(a) level of < 10%. Cohort B is defined by participants with a FVII(a) level of ≥10%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 60 years, inclusive, at the time of signing informed consent.
- •Diagnosis of FVIID defined by Factor VII:C activity < 10% documented on ≥ 2 different laboratory measurements by local laboratory assessment.
- •Severe bleeding history characterized by history of a major bleeding event and/or receipt of recombinant activated FVII or fresh frozen plasma as treatment for bleeding or a severe clinical bleeding history as defined by the Investigator.
- •Has the ability to provide informed consent to participate in the trial.
排除标准
- •Presence of known inhibitors to FVII or FVIIa
- •History of clinically significant hypersensitivity associated with monoclonal antibody therapies.
- •History of venous or arterial thrombosis or thromboembolic disease, with the exception of catheter-associated superficial vein thrombosis.
- •Known thrombophilia risk by the following criteria: Homozygous Factor V Leiden (FVL), compound heterozygous FVL/Prothrombin gene mutation, antithrombin <50%, congenital protein C, and protein S deficiency with levels <50%.
- •Clinically significant comorbidity that may interfere with study participation.
- •Use of concomitant therapy not permitted during the study (i.e., other platelet inhibitors, desmopressin, fibrinolysis inhibitors, except if used as local treatment [e.g., for oral bleeds])
- •Female participants who are pregnant or breastfeeding.
研究组 & 干预措施
Participants with a FVII(a) level of < 10%
Experimental
干预措施: Sutacimig (Drug)
Participants with a FVII(a) level of ≥10%
Experimental
干预措施: Sutacimig (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Day 1 through Day 57
次要结局
- Pharmacokinetic Parameter: Maximum observed plasma concentration (Cmax) of sutacimig(Day 1 through Day 57)
- Pharmacokinetic Parameter: Time to reach maximum observed plasma concentration (Tmax)(Baseline through Day 57)
- Pharmacokinetic Parameter: Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)(Day 1 through Day 57)
- Pharmacokinetic Parameter: Area under the curve from time zero to extrapolated infinite time (AUCinf)(Day 1 through Day 57)
- Pharmacokinetic Parameter: Terminal elimination phase half-life (T1/2)(Day 1 through Day 57)
- Pharmacodynamic Parameter: Total Factor VII(Day 1 through Day 57)
- Pharmacodynamic Parameter: Factor VII Activity(Day 1 through Day 57)
- Pharmacodynamic Parameter: Prothrombin time (PT) Measurement(Day 1 through Day 57)
- Pharmacodynamic Parameter: Activated partial thromboplastin time (aPTT) Measurement(Day 1 through Day 57)
- Anti-drug antibody levels(Day 1 through Day 57)
研究者
研究点 (1)
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