Overview

This trial is active, not recruiting.

Condition venous leg ulcer (vlu)
Treatments hp802-247, vehicle control, standard care
Phase phase 3
Sponsor Healthpoint
Start date May 2014
End date February 2016
Trial size 440 participants
Trial identifier NCT01970657, 802-247-09-033

Summary

This observational safety follow-up study will enroll 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 will participate depending upon subject enrollment from the previous study, 802-247-09-032. The study is going to be conducted in approximately 50 sites in Europe

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Standard Care plus HP802-247: (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts)260 µL (130 µL, one spray, of each solution) containing 0.5 X 10 6 cells per mL every 14 days
hp802-247
(fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts)
standard care
multi layer compression bandage system
(Placebo Comparator)
Standard Care plus Vehicle Control (fibrinogen solution & thrombin solution without cells)
vehicle control
(fibrinogen solution & thrombin solution without cells)
standard care
multi layer compression bandage system

Primary Outcomes

Measure
The primary objective of this study is to 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: 12 months

Secondary Outcomes

Measure
The secondary objective is to follow-up on the status of the target ulcer as open or closed.
time frame: 12 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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)
Principal investigator Wolfgang Vanscheidt, MD
Description The present study expects subjects to transition immediately upon exit from the 802-247-09-032 trial into a longer period of observation, ensuring a total of 12 months of safety and wound status data are obtained from the time of the first application of HP802-247. This study provides consecutive visits at intervals of 8 weeks until a total of 12 months of safety follow-up has been achieved, using the date of first application of Investigational Medicinal Product as reference start date and the exit from the 802-247-09-032 trial to determine the number of follow-up visits needed in this study to total 12 months of follow-up. Specifically, this study examines all new and unresolved ongoing adverse events.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Healthpoint.