NCT01853384

Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers

A Phase 3 Randomized Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (EU)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (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. 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.

Detailed description

See Brief Summary

Conditions

• Venous Ulcer
• Venous Stasis Ulcer
• Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	HP802-247	Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
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.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-12-01
• Completion: 2015-02-01
• First posted: 2013-05-15
• Last updated: 2016-10-03
• Results posted: 2016-10-03

Locations

46 sites across 5 countries: Belgium, Czechia, Germany, Hungary, Poland