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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01970657

Enrollment

221

Registered

2013-10-28

Start date

2014-05-31

Completion date

2015-11-30

Last updated

2017-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Leg Ulcer (VLU)

Keywords

Venous Stasis Ulcer, VLU

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.

Interventions

BIOLOGICALNo treatment

None specified

BIOLOGICALNo treatment specified

No intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Belgium, Czechia, Germany, Hungary, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026