Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.
At least 440 subjects will participate. The study is going to be conducted in approximately 5 countries at approximately 50 sites across the European Union.
Venous Stasis Ulcer
Other: HP802-247 Vehicle
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3 Randomized Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (EU)|
- Proportion of subjects with complete wound closure over the treatment period. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Time in days to complete wound closure from baseline over the 12 double-blind treatment weeks. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Proportion of subjects with complete wound closure at each of the 12 double-blind treatment weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Proportion of subjects with durable wound healing over the 3 months following complete wound closure. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Pain associated with the target wound and target leg at each of the 12 double blind treatment weeks using the Visual Analog Scale (VAS). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
Placebo Comparator: HP802-247 Vehicle
fibrinogen solution & thrombin solution without cells
Other: HP802-247 Vehicle
HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface. Subjects randomized to this intervention will receive applications weekly.
Other Name: Placebo
See Brief Summary
Please refer to this study by its ClinicalTrials.gov identifier: NCT01853384
Hide Study Locations
|Brno, Czech Republic|
|Hradec Kralove, Czech Republic|
|Olomouc, Czech Republic|
|Pardubice, Czech Republic|
|Plzen-Bory, Czech Republic|
|Praha, Czech Republic|
|Trebic, Czech Republic|
|Uherske Hradiste, Czech Republic|
|Usti nad Labem, Czech Republic|
|Study Chair:||Herbert B. Slade, MD||Smith & Nephew, Inc.|
|Study Director:||Tommy Lee, MSHS||Smith & Nephew, Inc.|
|Principal Investigator:||Wolfgang Vanscheidt, Professor Dr||University Freiburg-Practice for Dermatology|