Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

This study is currently recruiting participants.
Verified January 2014 by Healthpoint
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01656889
First received: August 1, 2012
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.


Condition Intervention Phase
Venous Leg Ulcers
Biological: HP-802-247
Biological: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Wound Closure [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Event [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 440
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HP802-247
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 106 cells per mL every 14 days.
Biological: HP-802-247
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 106 cells per mL every 14 days.
Placebo Comparator: Vehicle
Vehicle Control (fibrinogen solution & thrombin solution without cells)
Biological: Vehicle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide informed consent.
  • Age ≥ 18 years and of either sex.
  • Willing to comply with protocol instructions, including allowing all study assessments.
  • Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2
  • Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
  • Arterial supply adequacy confirmed
  • Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
  • Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
  • Acceptable state of health and nutrition

Exclusion Criteria:

  • History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B.
  • Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication.
  • Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
  • A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
  • Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
  • Refusal of or inability to tolerate compression therapy.
  • Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
  • History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
  • Any prior exposure to HP802-247 or its vehicle.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656889

Contacts
Contact: Nick D McCoy, BS 817-302-3924 nick.mccoy@healthpoint.com

  Hide Study Locations
Locations
United States, Arizona
Recruiting
Glendale, Arizona, United States, 85306
Recruiting
Phoenix, Arizona, United States, 85006
Recruiting
Phoenix, Arizona, United States, 85012
Recruiting
Tucson, Arizona, United States, 85724
Recruiting
Tucson, Arizona, United States, 85723
Contact: Houston    520-792-1450 ext 6525      
United States, California
Recruiting
Carlsbad, California, United States, 92009
Recruiting
Castro Valley, California, United States, 94546
Not yet recruiting
Fresno, California, United States, 93720
Recruiting
Laguna Hills, California, United States, 92653
Recruiting
Long Beach, California, United States, 90822
Not yet recruiting
Los Angeles, California, United States, 90095
Recruiting
San Diego, California, United States, 92013
Recruiting
San Francisco, California, United States, 94115
Contact: McCray    415-710-3061      
Recruiting
Stockton, California, United States, 95204
Recruiting
Sylmar, California, United States, 91342
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Terminated
Gainesville, Florida, United States, 32605
Terminated
Hialeah, Florida, United States, 33013
Recruiting
Miami, Florida, United States, 33125
Recruiting
South Miami, Florida, United States, 33143
Terminated
Tamarac, Florida, United States, 33321
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60611
Recruiting
Chicago, Illinois, United States, 60612
Recruiting
Chicago, Illinois, United States, 60616
Terminated
Jacksonville, Illinois, United States, 62650
Recruiting
North Chicago, Illinois, United States, 60064
Recruiting
Springfield, Illinois, United States, 62702
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02118
Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Cook    617-281-1780      
United States, Nevada
Recruiting
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Recruiting
Emerson, New Jersey, United States, 07630
United States, New York
Recruiting
New York, New York, United States, 10025
United States, North Carolina
Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Recruiting
Akron, Ohio, United States, 44307
United States, Oklahoma
Recruiting
Tulsa, Oklahoma, United States, 74127
United States, Pennsylvania
Completed
Dunmore, Pennsylvania, United States, 18512
Recruiting
Wyomissing, Pennsylvania, United States, 19610
United States, Texas
Terminated
Dallas, Texas, United States, 75390
Recruiting
Fort Worth, Texas, United States, 76107
Recruiting
Fort Worth, Texas, United States, 76104
Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
Recruiting
St. George, Utah, United States, 84770
United States, Virginia
Recruiting
Roanoke, Virginia, United States, 24013
United States, Washington
Recruiting
Tacoma, Washington, United States, 98431
Canada, British Columbia
Recruiting
Vancovuer, British Columbia, Canada, V5Z1M9
Canada, Ontario
Recruiting
Hamilton, Ontario, Canada, L8R2R3
Recruiting
London, Ontario, Canada, N6C5J1
Terminated
Sudbury, Ontario, Canada, P3E5J1
Canada, Quebec
Recruiting
Sherbrooke, Quebec, Canada, J1H5N4
Sponsors and Collaborators
Healthpoint
Smith & Nephew, Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01656889     History of Changes
Other Study ID Numbers: 802-247-09-029
Study First Received: August 1, 2012
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Healthpoint:
Venous leg ulcer
ulcer
venous stasis
compression
venous
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 April 16, 2014