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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01970657
First received: October 22, 2013
Last updated: June 21, 2017
Last verified: June 2017
  Purpose

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 Intervention
Venous Leg Ulcer (VLU) Biological: No treatment specified Biological: No treatment

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 221
Study Start Date: May 2014
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970657

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

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01970657     History of Changes
Other Study ID Numbers: 802-247-09-033
Study First Received: October 22, 2013
Last Updated: June 21, 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

ClinicalTrials.gov processed this record on September 21, 2017