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

Completed

• Conditions: Venous Leg Ulcer (VLU)
• Interventions: Biological: No treatment; Biological: No treatment specified

• Registration Number: NCT01970657
• Lead Sponsor: Healthpoint

Brief 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.

Study Timeline

• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-22
• Study First Posted: 2013-10-28
• Study Start: 2014-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

• The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams.
• Subject was randomized in 802-247-09-032 and received at least one application of test article.
• Subject has ended their participation in 802-247-09-032 by virtue of completing the study, or by dropping out prior to completion.

Exclusion Criteria

• Subjects who refuse to provide written informed consent for this study will be excluded from this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vehicle Control in prior study	No treatment	Observational safety follow up study, no treatment specified
HP802-247 in prior study	No treatment specified	Observational safety follow up study, no treatment specified

Primary Outcome Measures

Name	Time	Method
Assess new adverse events, and ongoing adverse events not resolved, in subjects who were exposed to a Investigational Medicinal Product in the 802-247-09-032 trial.	Up to 12 months from first application of test article in the 802-247-09-032 study	The evaluation of safety included analysis of new test article-related events, as well as continued follow-up of those adverse events that originated in the prior study.

Secondary Outcome Measures

Name	Time	Method
Follow-up on the status of the target ulcer as open, re-opened or closed.	Up to 12 months from first application of test article in the 802-247-09-032 study	At each study visit the status of the target ulcer was assessed as remaining closed, re-opened, or a new closure.