PeproStat Haemostat Study in Subjects Undergoing Liver Surgery

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haemostatix Ltd

Criteria

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