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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Venous Leg Ulcers	Biological: HP-802-247; Biological: Vehicle	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	447 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	August 2012
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Arm	Intervention/treatment
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; (fibrinogen solution & thrombin solution without cells)

Outcome Measures

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Primary Outcome Measures :

1. Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline [ Time Frame: 12 Weeks ]
   For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.

Secondary Outcome Measures :

1. Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline. [ Time Frame: 12 Weeks ]
   This key secondary outcome was based on a Cox Proportional Hazard Analysis and a Kaplan-Meier survival analysis.
2. Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline [ Time Frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first ]
   Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.
3. Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure [ Time Frame: Target ulcer status observed at two and three months following initial ulcer closure. ]
   Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.
4. Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks [ Time Frame: Weekly, over the 12 week treatment period, baseline ]
   Target leg pain were measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.
5. Change in Target Ulcer Pain [ Time Frame: Weekly, over 12 week treament period, baseline ]
   Target ulcer pain were measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.
6. Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline. [ Time Frame: 12 weeks ]
   This key secondary outcome was based on a Kaplan-Meier survival analysis.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

United States, Arizona
Glendale, Arizona, United States, 85306
Phoenix, Arizona, United States, 85006
Phoenix, Arizona, United States, 85012
Tucson, Arizona, United States, 85723
Tucson, Arizona, United States, 85724
United States, California
Carlsbad, California, United States, 92009
Castro Valley, California, United States, 94546
Fresno, California, United States, 93720
Laguna Hills, California, United States, 92653
Long Beach, California, United States, 90822
Los Angeles, California, United States, 90095
San Diego, California, United States, 92013
San Francisco, California, United States, 94115
Stockton, California, United States, 95204
Sylmar, California, United States, 91342
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Gainesville, Florida, United States, 32605
Hialeah, Florida, United States, 33013
Miami, Florida, United States, 33125
South Miami, Florida, United States, 33143
Tamarac, Florida, United States, 33321
United States, Illinois
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60616
Jacksonville, Illinois, United States, 62650
North Chicago, Illinois, United States, 60064
Springfield, Illinois, United States, 62702
United States, Maryland
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston, Massachusetts, United States, 02118
Cambridge, Massachusetts, United States, 02138
United States, Nevada
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Emerson, New Jersey, United States, 07630
United States, New York
New York, New York, United States, 10025
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Akron, Ohio, United States, 44307
United States, Oklahoma
Tulsa, Oklahoma, United States, 74127
United States, Pennsylvania
Dunmore, Pennsylvania, United States, 18512
Wyomissing, Pennsylvania, United States, 19610
United States, Texas
Dallas, Texas, United States, 75390
Fort Worth, Texas, United States, 76104
Fort Worth, Texas, United States, 76107
San Antonio, Texas, United States, 78229
United States, Utah
St. George, Utah, United States, 84770
United States, Virginia
Roanoke, Virginia, United States, 24013
United States, Washington
Tacoma, Washington, United States, 98431
Canada, British Columbia
Vancovuer, British Columbia, Canada, V5Z1M9
Canada, Ontario
Hamilton, Ontario, Canada, L8R2R3
London, Ontario, Canada, N6C5J1
Sudbury, Ontario, Canada, P3E5J1
Canada, Quebec
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Healthpoint
ClinicalTrials.gov Identifier:	NCT01656889 History of Changes
Other Study ID Numbers:	802-247-09-029
First Posted:	August 3, 2012
Results First Posted:	March 14, 2016
Last Update Posted:	March 14, 2016
Last Verified:	February 2016

Keywords provided by Healthpoint:

Venous leg ulcer; ulcer; venous stasis; compression	venous; venous stasis ulcer; vlu

Additional relevant MeSH terms:

Ulcer; Leg Ulcer; Varicose Ulcer; Pathologic Processes; Skin Ulcer; Skin Diseases; Varicose Veins	Vascular Diseases; Cardiovascular Diseases; Pharmaceutical Solutions; Thrombin; Hemostatics; Coagulants