Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
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|ClinicalTrials.gov Identifier: NCT01737762|
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
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).
At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.
|Condition or disease||Intervention/treatment||Phase|
|Venous Leg Ulcers||Biological: HP802-247 Biological: Vehicle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||155 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2|
|Study Start Date :||November 2012|
|Primary Completion Date :||November 2015|
|Study Completion Date :||November 2015|
HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.
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 x106 cells per mL every 14 days.
Placebo Comparator: Vehicle
Vehicle Control(fibrinogen solution & thrombin solution without cells)
- Wound Closure [ Time Frame: 16 Weeks ]Compare HP802-247 plus compression therapy against Vehicle plus compression therapy for proportion of subjects with complete wound closure over the 16-week treatment period from baseline.
- Time in Days to Closure [ Time Frame: 16 Weeks ]Compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure, based on time in days to closure over the 16-week treatment period from baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737762
Show 43 Study Locations
|Study Chair:||Herbert B Slade, MD||Healthpoint|
|Study Director:||Tommy Lee, MSHS||Healthpoint|
|Principal Investigator:||Robert Kirsner, MD||University of Miami|
|Principal Investigator:||William Marston, MD||University of North Carolina|