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)

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.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer (VLU)
• Intervention / Treatment: Biological: No treatment specified; Biological: No treatment

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 Type: Observational
• Enrollment (Actual): 221

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
  • Edegem, Belgium
  • Gent, Belgium
• Czechia
  • Brno, Czechia
  • Hradec Kralove, Czechia
  • Olomouc, Czechia
  • Pardubice, Czechia
  • Plzen-Bory, Czechia
  • Praha, Czechia
  • Trebic, Czechia
  • Uherske Hradiste, Czechia
  • Usti nad Labem, Czechia
• Germany
  • Bochum, Germany
  • Bonn, Germany
  • Dresden, Germany
  • Duesseldorf, Germany
  • Essen, Germany
  • Freiburg, Germany
  • Goettingen, Germany
  • Greifswald, Germany
  • Hamburg, Germany
  • Kiel, Germany
  • Koeln, Germany
  • Krefeld, Germany
  • Magdeburg, Germany
  • Muenchen, Germany
  • Muenster, Germany
• Hungary
  • Budapest, Hungary
  • Debrecen, Hungary
  • Hatvan, Hungary
  • Oroshaza, Hungary
  • Satoraljaujhely, Hungary
  • Szeged, Hungary
  • Szolnok, Hungary
• Poland
  • Krakow, Poland
  • Lodz, Poland
  • Lublin, Poland
  • Poznan, Poland
  • Rzeszow, Poland
  • Studzionka, Poland
  • Warszawa, Poland
  • Wroclaw, Poland
  • Zabrze, Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HP802-247 in prior study; Observational safety follow up study, no treatment specified	Biological: No treatment specified; No intervention
Vehicle Control in prior study; Observational safety follow up study, no treatment specified	Biological: No treatment; None specified

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Healthpoint
• Investigators: Principal Investigator: Wolfgang Vanscheidt, MD, University Freiburg-Practice for Dermatology

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 22, 2013
• First Posted (Estimate): October 28, 2013

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: VLU; Venous Stasis Ulcer
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: 802-247-09-033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication submitted to Journal of Vascular Surgery in May 2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No