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

Venous Leg Ulcer (VLU) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970657
• Other study ID #: 802-247-09-033
• Status: Completed
• Phase: N/A
• First received: October 22, 2013
• Last updated: June 21, 2017
• Start date: May 2014
• Est. completion date: November 2015

Study information

• Verified date: June 2017
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Varicose Ulcer
• Venous Leg Ulcer (VLU)

Intervention

Biological:
• No treatment specified
No intervention
• No treatment
None specified

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Countries where clinical trial is conducted

Belgium,  Czechia,  Germany,  Hungary,  Poland, 

Outcome

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