Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2

NCT01737762 | Completed Phase 3 Results DMC

• 1 other identifier: 802-247-09-031
• Study Type: interventional
• Target: 155
• Locations: 3 countries
• Sites: 43

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). At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.

Conditions

Venous Leg Ulcers

Keywords

Venous leg ulcer; ulcer; Venous stasis; compression; venous; venous stasis ulcer; vlu; wound; varicose veins; venous insufficiency; dvt; deep vein thrombosis

Outcome Measures

Primary Outcomes (1)

• Wound Closure

  Compare HP802-247 plus compression therapy against Vehicle plus compression therapy for proportion of subjects with complete wound closure over the 16-week treatment period from baseline.

  16 Weeks

Secondary Outcomes (1)

• Time in Days to Closure

  16 Weeks

Study Arms (2)

HP802-247

EXPERIMENTAL

HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.

Biological: HP802-247

Vehicle

PLACEBO COMPARATOR

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

Biological: Vehicle

Interventions

HP802-247 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 x106 cells per mL every 14 days.

HP802-247

Vehicle BIOLOGICAL

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 \>12 cm2 to ≤ 36 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

Study Sites (43)

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Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85012, United States

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Phoenix, Arizona, 85015, 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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Fair Oaks, California, 95608, 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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Sylmar, California, 91342, United States

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Washington D.C., District of Columbia, 20007, 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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Chicago, Illinois, 60611, United States

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Jacksonville, Illinois, 62650, 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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Saginaw, Michigan, 48602, United States

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Washington, Missouri, 63090, United States

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Las Vegas, Nevada, 89119, United States

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Bayonne, New Jersey, 07002, United States

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Hoboken, New Jersey, 07030, United States

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East Meadow, New York, 11554, 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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Willoughby, Ohio, 44094, 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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Knoxville, Tennessee, 37909, United States

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Fort Worth, Texas, 76107, United States

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Tacoma, Washington, 98431, United States

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Calgary, Alberta, T2T5C7, Canada

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Winnipeg, Manitoba, R3A1R9, 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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San Juan, 00909-1711, Puerto Rico

Location

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; Wounds and Injuries; Varicose Veins; Venous Insufficiency; Venous Thrombosis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The trial was terminated due to the failure of the Phase 3 study

Results Point of Contact

• Title: Dr Innes Cargill
• Organization: Smith and Nephew

innes.cargill@smith-nephew.com

817-302-3913

Study Officials

• Herbert B Slade, MD

  Healthpoint

  STUDY CHAIR

• Tommy Lee, MSHS

  Healthpoint

  STUDY DIRECTOR

• Robert Kirsner, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• William Marston, MD

  University of North Carolina

  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: November 20, 2012
• First Posted: November 30, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 26, 2017
• Results First Posted: July 26, 2017

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

PR (1); US (37); CA (5)