Clinical trial NCT02204930: PeproStat Haemostat Study in Subjects Undergoing Liver Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemorrhage
Keywords: 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
Lead sponsor: Haemostatix Ltd
Sponsor class: INDUSTRY
First posted: 2014-07-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility 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

Primary outcomes:
measure: Safety of PeproStat
timeFrame: within 30 days after surgery and study treatment
Secondary outcomes:
measure: Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery
timeFrame: During surgery
measure: Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery
timeFrame: During surgery
measure: Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery
timeFrame: During surgery
measure: Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery
timeFrame: During surgery
Other outcomes:
measure: Exploratory Immunogenicity
timeFrame: within 30 days after surgery and study treatment
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's University Hospital
city: London
country: United Kingdom
facility: Kings University Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
affiliation: The Queen Elizabeth Hospital
name: D Mirza, MBBS, MS, FRCS
role: PRINCIPAL_INVESTIGATOR
References: