HemorrhagePhase 1NCT02204930
PeproStat Haemostat Study in Subjects Undergoing Liver Surgery
A Phase 1 study testing PeproStat in people with Hemorrhage, run by Haemostatix Ltd at 4 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage
- What is being tested?
- PeproStat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jul 2014to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Queen Elizabeth Hospital
Birmingham, B15 2TH
Addenbrooke's University Hospital
Cambridge, CB2 0QQ
Kings University Hospital
London, SE5 9RS
Derriford Hospital
Plymouth, PL6 8DH
About this study
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
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
- Being tested
- PeproStat
- 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
- Medical subject headings
- Hemorrhage, Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeproStatDrug
A solution of PeproStat containing up to 9.25mg protein soaked immediately prior to use onto a Gelita-Spon® gelatin sponge.
| Study group | Role | What they receive |
|---|---|---|
| Haemostat | Experimental | PeproStat Receives: Drug: PeproStat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of PeproStat
Incidence, severity, and relatedness of adverse events (AEs) and adverse drug reactions (ADRs).
Measured: within 30 days after surgery and study treatment
Secondary outcomes (4)
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.
Measured: During surgery
Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery
Mean time to haemostasis.
Measured: 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.
Measured: 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.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haemostatix Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- D Mirza, MBBS, MS, FRCS, Principal investigator, The Queen Elizabeth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204930
- Sponsor's protocol ID
- HX-01-UK
- Other IDs
- 2013-001993-10
- Status last verified
- Oct 2015
- First submitted
- 29 Jul 2014
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02204930
- Acronym / sponsor ID
- HX-01-UK
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Haemostatix LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Haemostat | Experimental | Drug: PeproStatPeproStat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeproStatA solution of PeproStat containing up to 9.25mg protein soaked immediately prior to use onto a Gelita-Spon® gelatin sponge. | Drug | Haemostat |
Primary outcome
Safety of PeproStat
Time frame: within 30 days after surgery and study treatment
Incidence, severity, and relatedness of adverse events (AEs) and adverse drug reactions (ADRs).
4 secondary outcomes
Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery
Time frame: During surgery
Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery
Time frame: During surgery
Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery
Time frame: During surgery
Assessment of efficacy of PeproStat in achieving haemostasis in open liver resection surgery
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D Mirza, MBBS, MS, FRCS principal investigator
The Queen Elizabeth Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PeproStat in people with Hemorrhage, run by Haemostatix Ltd at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of PeproStat (time frame: within 30 days after surgery and study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.