Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers

NCT01853384 | Terminated Phase 3 Results DMC

• 2 other identifiers: 802-247-09-0322012-003286-18
• Study Type: interventional
• Target: 252
• Locations: 5 countries
• Sites: 46

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. At least 440 subjects will participate. The study is going to be conducted in approximately 5 countries at approximately 50 sites across the European Union.

Conditions

Venous Ulcer; Venous Stasis Ulcer; Ulcer

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)

• Compare the Treatment Groups for the Number 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 prior to the end of treatment, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.

  Weekly, over 12 Weeks or until wound closure, which ever occurred first

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 Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Median Time (Days) to Closure Over the 12-Week Treatment Period From Baseline.

  12 weeks

• Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each 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 (visit 1) and three (visit 2) months following initial ulcer closure.

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

  Baseline and Weekly, over the 12 week treatment period

Study Arms (2)

HP802-247 plus compression therapy

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 10(6th) cells per mL every 14 days. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.

Biological: HP802-247

HP802-247 Vehicle plus compression therapy

PLACEBO COMPARATOR

fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly.

Other: HP802-247 Vehicle

Interventions

HP802-247 BIOLOGICAL

Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.

HP802-247 plus compression therapy

HP802-247 Vehicle OTHER

HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.

Also known as: Placebo

HP802-247 Vehicle plus compression therapy

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

Study Sites (46)

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Anderlecht, Belgium

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Brussels, Belgium

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Edegen, Belgium

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Ghent, Belgium

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Kortrijk, Belgium

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Brno, Czechia

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Hradec Králové, Czechia

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Olomouc, Czechia

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Pardubice, Czechia

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Plzen-Bory, Czechia

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Prague, Czechia

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Třebíč, Czechia

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Uherské Hradiště, Czechia

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Ústí nad Labem, Czechia

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Bochum, Germany

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Bonn, Germany

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Cologne, Germany

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Dresden, Germany

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Düsseldorf, Germany

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Essen, Germany

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Freiburg im Breisgau, Germany

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Göttingen, Germany

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Greifswald, Germany

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Hamburg, Germany

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Kiel, Germany

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Krefeld, Germany

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Magdeburg, Germany

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München, Germany

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Münster, Germany

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Budapest, Hungary

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Debrecen, Hungary

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Hatvan, Hungary

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Orosháza, Hungary

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Sátoraljaújhely, Hungary

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Szeged, Hungary

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Szolnok, Hungary

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Katowice, Poland

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Krakow, Poland

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Lodz, Poland

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Lublin, Poland

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Poznan, Poland

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Rzeszów, Poland

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Studzionka, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Zabrze, Poland

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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; 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

Results Point of Contact

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

Jaime.Dickerson@smith-nephew.com

1-817-302-3914

Study Officials

• Herbert B. Slade, MD

  Smith & Nephew, Inc.

  STUDY CHAIR

• Tommy Lee, MSHS

  Smith & Nephew, Inc.

  STUDY DIRECTOR

• Wolfgang Vanscheidt, Professor Dr

  University Freiburg-Practice for Dermatology

  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: May 8, 2013
• First Posted: May 15, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: October 3, 2016
• Results First Posted: October 3, 2016

Record last verified: 2016-09

Locations

HU (7); DE (15); CZ (9); BE (5); PL (10)