PeproStat Haemostat Study in Subjects Undergoing Liver Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hemorrhage

Intervention / Treatment
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* Drug: PeproStat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Haemostat<br>PeproStat | Drug: PeproStat<br>* A solution of PeproStat containing up to 9.25mg protein soaked immediately prior to use onto a Gelita-Spon® gelatin sponge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of PeproStat | Incidence, severity, and relatedness of adverse events (AEs) and adverse drug reactions (ADRs). | within 30 days after surgery and study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery | Percentages of subjects who achieve haemostasis within 3, 5, 7 and 10 minutes following application for the first five subjects and at 1, 3, 5, 7 & 10 minutes following application in subsequent subjects. | During surgery | 
| Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery | Mean time to haemostasis. | During surgery | 
| Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery | Percentage of subjects who do not achieve haemostasis within 10 minutes. | During surgery | 
| Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery | Administered dose of PeproStat determined by number of sponges administered to a single bleeding site. | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemostat, Liver surgery, Primary liver cancer, Metastatic liver cancer, Benign liver disease such as adenoma, Hepatitis-related or alcoholic-related liver cirrhosis, Living donation for liver transplant