NCT01656889

Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 447 (actual)
• Sponsor: Healthpoint · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Venous Leg Ulcers

Interventions

Type	Name	Description
BIOLOGICAL	HP-802-247	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 106 cells per mL every 14 days.
BIOLOGICAL	Vehicle	(fibrinogen solution \& thrombin solution without cells)

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-08-03
• Last updated: 2016-03-14
• Results posted: 2016-03-14

Locations

50 sites across 2 countries: United States, Canada