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

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ClinicalTrials.gov Identifier: NCT01970657
Recruitment Status : Completed
First Posted : October 28, 2013
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Venous Leg Ulcer (VLU) 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
Actual Enrollment : 221 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : May 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   None Retained
The treatment assignment codes and randomization schedule for the prior trial will be maintained for this observational study. The treatment assignments will not be made known to the Investigators until the present follow-up study has been completed by all consenting subjects thus keeping treating physician and subjects blind to treatment.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970657


  Show 43 Study Locations
Sponsors and Collaborators
Healthpoint
Investigators
Principal Investigator: Wolfgang Vanscheidt, MD University Freiburg-Practice for Dermatology

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01970657     History of Changes
Other Study ID Numbers: 802-247-09-033
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication submitted to Journal of Vascular Surgery in May 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Healthpoint:
Venous Stasis Ulcer
VLU

Additional relevant MeSH terms:
Leg Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases