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 Ulcer Venous Stasis Ulcer Ulcer||Biological: HP802-247 Other: HP802-247 Vehicle||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)|
- Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline [ Time Frame: Weekly, over 12 Weeks or until wound closure, which ever occurred first ]
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed.
For subjects who dropped from the study prior to the end of treatment, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.
- Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline. [ Time Frame: 12 Weeks ]This key secondary outcome was based on a Cox Proportional Hazard Analysis.
- Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Median Time (Days) to Closure Over the 12-Week Treatment Period From Baseline. [ Time Frame: 12 weeks ]This key secondary outcome was based on a Kaplan-Meier Survival analysis.
- Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline [ Time Frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first ]For subjects who dropped from the study, their remaining visit values were imputed using LOCF. Treatment groups were compared for percentage of participants with closed wounds at each treatment visit.
- Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure [ Time Frame: Target ulcer status observed at two (visit 1) and three (visit 2) months following initial ulcer closure. ]Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.
- Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks [ Time Frame: Baseline and Weekly, over the 12 week treatment period ]Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.
- Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks [ Time Frame: Baseline and Weekly, over the 12 week treatment period ]Target leg pain were measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.
|Study Start Date:||November 2013|
|Study Completion Date:||February 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: HP802-247 plus compression therapy
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. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
Placebo Comparator: HP802-247 Vehicle plus compression therapy
fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly.
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.
Other Name: Placebo
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|