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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01970657
First received: October 22, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Venous Leg Ulcer (VLU)
Biological: HP802-247
Other: Vehicle Control
Other: Standard Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Smith & Nephew, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective is to follow-up on the status of the target ulcer as open or closed. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: May 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard Care plus HP802-247
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
Biological: HP802-247
(fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts)
Other: Standard Care
multi layer compression bandage system
Placebo Comparator: Standard Care plus Vehicle Control
Standard Care plus Vehicle Control (fibrinogen solution & thrombin solution without cells)
Other: Vehicle Control
(fibrinogen solution & thrombin solution without cells)
Other: Standard Care
multi layer compression bandage system

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Smith & Nephew, Inc.
Investigators
Principal Investigator: Wolfgang Vanscheidt, MD University Freiburg-Practice for Dermatology
  More Information

No publications provided

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01970657     History of Changes
Other Study ID Numbers: 802-247-09-033
Study First Received: October 22, 2013
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Germany: Ethics Commission
Germany: Paul-Ehrlich-Institut
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Hungary: Research Ethics Medical Committee
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Smith & Nephew, Inc.:
Venous Stasis Ulcer
VLU

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

ClinicalTrials.gov processed this record on August 18, 2014