NCT00852995

Dose Finding Study of HP802-247 in Venous Leg Ulcers

A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Healthpoint · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.

Conditions

• Venous Leg Ulcer
• Venous Stasis Ulcers

Interventions

Type	Name	Description
BIOLOGICAL	HP802-247	One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
BIOLOGICAL	Placebo (Vehicle)	Placebo (Vehicle) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-04-01
• Completion: 2011-07-01
• First posted: 2009-02-27
• Last updated: 2016-10-24
• Results posted: 2016-03-14

Locations

30 sites across 2 countries: United States, Canada