Trials / Completed
CompletedNCT02204930
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Haemostatix Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PeproStat | A solution of PeproStat containing up to 9.25mg protein soaked immediately prior to use onto a Gelita-Spon® gelatin sponge. |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2015-09-01
- Completion
- 2015-09-01
- First posted
- 2014-07-31
- Last updated
- 2015-10-21
Locations
4 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02204930. Inclusion in this directory is not an endorsement.