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NCT Number: NCT01970657

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

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.

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Key information

Conditions

Venous Leg Ulcer (VLU) Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No treatment specified

Biological

No intervention

No treatment

Biological

None specified

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Follow-up on the status of the target ulcer as open, re-opened or closed.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Healthpoint

Industry

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 28, 2013
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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