NCT01737762

Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 155 (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). At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.

Detailed description

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 16-week treatment period. Vehicle looks the same as HP802-247 but contains no cells. Target wound status is evaluated at each study visit (closed, open, reopened). At wound closure or completion of treatment all subject will enter an observational safety followed up period which ends at one year after initial exposure to test article.

Conditions

• Venous Leg Ulcers

Interventions

Type	Name	Description
BIOLOGICAL	HP802-247	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 x106 cells per mL every 14 days.
BIOLOGICAL	Vehicle

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2012-11-30
• Last updated: 2017-07-26
• Results posted: 2017-07-26

Locations

43 sites across 3 countries: United States, Canada, Puerto Rico