PeproStat Haemostat Study in Subjects Undergoing Liver Surgery

Haemostatix

Status and phase

Completed

Phase 1

Conditions

Hemorrhage

Treatments

Drug: PeproStat

Study type

Interventional

Funder types

Industry

Identifiers

NCT02204930

2013-001993-10 (EudraCT Number)

HX-01-UK

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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