NCT01658618

Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer

A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 440 (estimated)
• Sponsor: Healthpoint · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle (an inactive substance). This study is being done for the following purposes: 1. to identify new adverse events, 2. to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial, 3. to record wound status, and 4. to determine if there are differences in Health Related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-029 Trial. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	HP802-247

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-03-01
• Completion: 2015-05-01
• First posted: 2012-08-07
• Last updated: 2014-02-03

Locations

49 sites across 2 countries: United States, Canada