NCT01970657

Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247

An Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247 in Subjects Who Participated in Study 802-247-09-032(EU)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 221 (actual)
• Sponsor: Healthpoint · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational safety follow-up study enrolled subjects from the 802-247-09-032 study with the investigational product HP802-247 for venous leg ulcers, who received at least one application of HP802-247 or Vehicle (Placebo). 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 802-247-09-032 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 802-247-09-032 Trial. About 440 subjects were to participate depending upon subject enrollment from the previous study, 802-247-09-032. The study was conducted in approximately 50 sites in Europe.

Detailed description

Subjects transitioned to this observational study immediately upon exit from the 802-247-09-032 trial. This ensured a total of 12 months of safety observations and wound status data were obtained from the time of the first application of HP802-247. This study provided consecutive visits at intervals of 8 weeks until a total of 12 months of safety follow-up had been achieved, based on the initial application of Investigational Medicinal Product in the prior study. Specifically, this study examines all new and unresolved ongoing adverse events.

Conditions

• Venous Leg Ulcer (VLU)

Interventions

Type	Name	Description
BIOLOGICAL	No treatment specified	No intervention
BIOLOGICAL	No treatment	None specified

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2013-10-28
• Last updated: 2017-06-22

Locations

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

Regulatory

• FDA-regulated drug study