NCT02204930已完成1 期
A Multi-centre, Open-label, Uncontrolled, First-in-Human Study to Evaluate the Safety and Tolerability and Explore the Efficacy of PeproStat in Gelita-Spon® Gelatin Sponge in Subjects Undergoing Open Liver Resection Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Safety of PeproStat
研究概览
简要总结
The purpose of this First in Man study is to evaluate the safety and tolerability, as well as to explore efficacy of PeproStat, a new peptide based coagulant (haemostat), when used in patients undergoing open liver resection surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Are able and willing to provide written informed consent to participate in this study, confirmed by signing the informed consent documents
- •Adult males and females ≥18 years of age
- •Female subjects must be post-menopausal. Post-menopausal status is defined as any of the following: natural menopause with menses >1 year ago; radiation induced oophorectomy with last menses >1 year ago; chemotherapy induced menopause with 1 year interval since last menses
- •Willing and able to comply with all protocol requirements including follow-up
- •Subject must have a haemoglobin ≥ 9.0 g/dL at screening
- •Subject must have a platelet count ≥ 100,000/mm3 at screening
- •Subject is undergoing a planned open liver resection
- •Male subjects must be willing and able to use adequate contraception from enrollment through to the 30 day follow-up visit
- •During the surgery, the subject presents an identified target bleeding site (TBS) with oozing, mild or moderate bleeding, which conventional surgical techniques are insufficient to control and would otherwise be a candidate for standard haemostats
- •During the surgery, subject presents no intraoperative complications, other than bleeding, that may interfere with study assessments as judged by the investigator
排除标准
- •Subject is undergoing emergency surgical procedure
- •Recipient of a liver transplant
- •Females of child-bearing potential
- •Active infection at the time of the liver resection
- •International Normalized Ratio (INR) > 2.0 or APTT ratio > 2.0 at screening
- •Fibrinogen level < 1.5g/L at screening
- •History of thromboembolic disease and/or thrombophilia
- •Any other disease or condition that may affect normal blood clotting, for example thrombocytopenia, as judged by the investigator
- •A known history of anaphylaxis or allergic reaction to human albumin, PEGylated proteins, yeast or moulds, porcine products or other components in the IMP
- •Participation in another investigational drug or device research study within 30 days before and after enrolment in the current study
- •Current known or suspected alcohol and/or drug abuse or dependence at the time of screening
- •Any concurrent medical, surgical, or psychiatric condition that may, in the investigator's opinion, affect the subject's willingness or ability to meet all study requirements during the study duration
- •During the surgery, subject presents severe bleeding where use of a topical haemostat would be inappropriate
- •Subject is taking any prohibited medications
- •BMI at screening of ≥35
研究组 & 干预措施
Haemostat
Experimental
PeproStat
干预措施: PeproStat (Drug)
结局指标
主要结局
Safety of PeproStat
时间窗: within 30 days after surgery and study treatment
Incidence, severity, and relatedness of adverse events (AEs) and adverse drug reactions (ADRs).
次要结局
- Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery(During surgery)
研究者
研究点 (4)
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