PeproStat Haemostat Study in Subjects Undergoing Liver Surgery

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204930
• Other study ID #: HX-01-UK
• Secondary ID: 2013-001993-10
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2014
• Last updated: October 20, 2015
• Start date: July 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Haemostatix Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Drug:
• PeproStat
A solution of PeproStat containing up to 9.25mg protein soaked immediately prior to use onto a Gelita-Spon® gelatin sponge.

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Addenbrooke's University Hospital	Cambridge
United Kingdom	Kings University Hospital	London
United Kingdom	Derriford Hospital	Plymouth

Sponsors (1)

Lead Sponsor	Collaborator
Haemostatix Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Safety of PeproStat	Incidence, severity, and relatedness of adverse events (AEs) and adverse drug reactions (ADRs).	within 30 days after surgery and study treatment	Yes
Secondary	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	No
Secondary	Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery	Mean time to haemostasis.	During surgery	No
Secondary	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	No
Secondary	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	No