PeproStat Haemostat Study in Subjects Undergoing Liver Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Drug: PeproStat

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's University Hospital
  • London, United Kingdom, SE5 9RS
    • Kings University Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Immunogenicity	Immunogenicity to be investigated using a specific antibody test which has been established but not yet validated.	within 30 days after surgery and study treatment

Collaborators and Investigators

• Sponsor: Haemostatix Ltd
• Investigators: Principal Investigator: D Mirza, MBBS, MS, FRCS, The Queen Elizabeth Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): July 31, 2014

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Metastatic liver cancer; Primary liver cancer; Liver surgery; Haemostat; Benign liver disease such as adenoma; Hepatitis-related or alcoholic-related liver cirrhosis; Living donation for liver transplant
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: HX-01-UK; 2013-001993-10 (EudraCT Number)