Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer
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|ClinicalTrials.gov Identifier: NCT01658618|
Recruitment Status : Unknown
Verified January 2014 by Healthpoint.
Recruitment status was: Enrolling by invitation
First Posted : August 7, 2012
Last Update Posted : February 3, 2014
This observations safety study is intended for subject who participated in the 802-247-09-029 study with the investigational product HP802-247 for venous leg ulcers and received at least one application of HP802-247 or Vehicle (an inactive substance). This study is being done for the following purposes:
- to identify new adverse events,
- to examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial,
- to record wound status, and
- to determine if there are differences in Health Related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-029 Trial.
Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
|Condition or disease||Intervention/treatment|
|Venous Leg Ulcer||Biological: HP802-247|
|Study Type :||Observational|
|Estimated Enrollment :||440 participants|
|Official Title:||A Non-Interventional Safety Study Providing 12 Months Follow-up From First Exposure to HP802-247 in Subjects With Venous Leg Ulcer|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||May 2015|
- Primary Objective [ Time Frame: 12 months ]The objectives of this study are to identify new adverse events, examine ongoing adverse events not resolved in subjects who participated in the 802-247-09-029 trial, and record wound status.
- Exploratory Objectives [ Time Frame: 12 Months ]The Health Economic objective for this study is to determine if there are differences in Health related Quality of Life (HRQoL) associated with the treatment assignment from the 802-247-09-029 Trial.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658618
Show 49 Study Locations
|Study Chair:||Herbert B Slade, MD||Chief Medical Officer|
|Study Director:||Tommy Lee, MSHS||Associate Director Clinical Operations|
|Principal Investigator:||Robert Kirsner, MD||Investigator|
|Principal Investigator:||William Marston, MD||Investigator|