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

NCT01656889 | Completed Phase 3 Results DMC

• 1 other identifier: 802-247-09-029
• Study Type: interventional
• Target: 447
• Locations: 2 countries
• Sites: 50

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.

Conditions

Venous Leg Ulcers

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline

  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.

  12 Weeks

Secondary Outcomes (6)

• 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.

  12 Weeks

• Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline

  Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first

• Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure

  Target ulcer status observed at two and three months following initial ulcer closure.

• Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks

  Weekly, over the 12 week treatment period, baseline

• Change in Target Ulcer Pain

  Weekly, over 12 week treament period, baseline

Study Arms (2)

HP802-247

EXPERIMENTAL

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

Vehicle

PLACEBO COMPARATOR

Vehicle Control (fibrinogen solution \& thrombin solution without cells)

Biological: Vehicle

Interventions

HP-802-247 BIOLOGICAL

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.

HP802-247

Vehicle BIOLOGICAL

(fibrinogen solution \& thrombin solution without cells)

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Healthpoint: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (50)

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Glendale, Arizona, 85306, United States

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Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85012, United States

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Tucson, Arizona, 85723, United States

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Tucson, Arizona, 85724, United States

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Carlsbad, California, 92009, United States

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Castro Valley, California, 94546, United States

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Fresno, California, 93720, United States

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Laguna Hills, California, 92653, United States

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Long Beach, California, 90822, United States

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Los Angeles, California, 90095, United States

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San Diego, California, 92013, United States

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San Francisco, California, 94115, United States

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Stockton, California, 95204, United States

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Sylmar, California, 91342, United States

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Washington D.C., District of Columbia, 20007, United States

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Gainesville, Florida, 32605, United States

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Hialeah, Florida, 33013, United States

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Miami, Florida, 33125, United States

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South Miami, Florida, 33143, United States

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Tamarac, Florida, 33321, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60612, United States

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Chicago, Illinois, 60616, United States

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Jacksonville, Illinois, 62650, United States

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North Chicago, Illinois, 60064, United States

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Springfield, Illinois, 62702, United States

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Baltimore, Maryland, 21224, United States

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Boston, Massachusetts, 02118, United States

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Cambridge, Massachusetts, 02138, United States

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Las Vegas, Nevada, 89119, United States

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Emerson, New Jersey, 07630, United States

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New York, New York, 10025, United States

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Chapel Hill, North Carolina, 27599, United States

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Akron, Ohio, 44307, United States

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Tulsa, Oklahoma, 74127, United States

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Dunmore, Pennsylvania, 18512, United States

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Wyomissing, Pennsylvania, 19610, United States

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Dallas, Texas, 75390, United States

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Fort Worth, Texas, 76104, United States

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Fort Worth, Texas, 76107, United States

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San Antonio, Texas, 78229, United States

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St. George, Utah, 84770, United States

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Roanoke, Virginia, 24013, United States

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Tacoma, Washington, 98431, United States

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Vancovuer, British Columbia, V5Z1M9, Canada

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Greater Sudbury, Ontario, P3E5J1, Canada

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Hamilton, Ontario, L8R2R3, Canada

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London, Ontario, N6C5J1, Canada

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Sherbrooke, Quebec, J1H5N4, Canada

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Related Publications (1)

• Marston WA, Ennis WJ, Lantis JC 2nd, Kirsner RS, Galiano RD, Vanscheidt W, Eming SA, Malka M, Cargill DI, Dickerson JE Jr, Slade HB; HP802-247 Study Group. Baseline factors affecting closure of venous leg ulcers. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):829-835.e1. doi: 10.1016/j.jvsv.2017.06.017.

  PMID: 29037354 DERIVED

MeSH Terms

Conditions

Varicose Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jaime E Dickerson, PhD
• Organization: Smith & Nephew

Jaime.Dickerson@smith-nephew.com

1-817-302-3914

Study Officials

• Herbert B Slade, MD

  Chief Medical Officer

  STUDY CHAIR

• Tommy Lee, MSHS

  Associate Director Clinical Operations

  STUDY DIRECTOR

• Robert Kirsner, MD

  Investigator

  PRINCIPAL INVESTIGATOR

• William Marston, MD

  Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 3, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 14, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Locations

CA (5); US (45)