PeproStat Haemostat Study in Subjects Undergoing Liver Surgery

NCT02204930 | Completed Phase 1

• 2 other identifiers: HX-01-UK2013-001993-10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery

  During surgery

• Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery

  During surgery

• Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery

  During surgery

• Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery

  During surgery

Other Outcomes (1)

• Exploratory Immunogenicity

  within 30 days after surgery and study treatment

Study Arms (1)

Haemostat

EXPERIMENTAL

PeproStat

Drug: PeproStat

Interventions

PeproStat DRUG

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

Haemostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haemostatix Ltd: lead

Study Sites (4)

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Addenbrooke's University Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Kings University Hospital

London, SE5 9RS, United Kingdom

Location

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Hemorrhage; Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• D Mirza, MBBS, MS, FRCS

  The Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 31, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

GB (4)