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

NCT ID: NCT01853384

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-02-28

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.

Detailed Description

See Brief Summary

Conditions

Venous Ulcer; Venous Stasis Ulcer; Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HP802-247 plus compression therapy

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.

Group Type: EXPERIMENTAL

HP802-247

Intervention Type: 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 Vehicle plus compression therapy

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

Group Type: PLACEBO_COMPARATOR

HP802-247 Vehicle

Intervention Type: 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.

Interventions

HP802-247

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

Intervention Type: BIOLOGICAL

HP802-247 Vehicle

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.

Intervention Type: OTHER

Other Intervention Names

Placebo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Healthpoint

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert B. Slade, MD

Role: STUDY_CHAIR

Smith & Nephew, Inc.

Tommy Lee, MSHS

Role: STUDY_DIRECTOR

Smith & Nephew, Inc.

Wolfgang Vanscheidt, Professor Dr

Role: PRINCIPAL_INVESTIGATOR

University Freiburg-Practice for Dermatology

Locations

Anderlecht, , Belgium

Brussels, , Belgium

Edegen, , Belgium

Ghent, , Belgium

Kortrijk, , Belgium

Brno, , Czechia

Hradec Králové, , Czechia

Olomouc, , Czechia

Pardubice, , Czechia

Plzen-Bory, , Czechia

Prague, , Czechia

Třebíč, , Czechia

Uherské Hradiště, , Czechia

Ústí nad Labem, , Czechia

Bochum, , Germany

Bonn, , Germany

Cologne, , Germany

Dresden, , Germany

Düsseldorf, , Germany

Essen, , Germany

Freiburg im Breisgau, , Germany

Göttingen, , Germany

Greifswald, , Germany

Hamburg, , Germany

Kiel, , Germany

Krefeld, , Germany

Magdeburg, , Germany

München, , Germany

Münster, , Germany

Budapest, , Hungary

Debrecen, , Hungary

Hatvan, , Hungary

Orosháza, , Hungary

Sátoraljaújhely, , Hungary

Szeged, , Hungary

Szolnok, , Hungary

Katowice, , Poland

Krakow, , Poland

Lodz, , Poland

Lublin, , Poland

Poznan, , Poland

Rzeszów, , Poland

Studzionka, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Zabrze, , Poland

Countries

Belgium; Czechia; Germany; Hungary; Poland

References

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.

Reference Type: DERIVED

PMID: 29037354 (View on PubMed)

Other Identifiers

2012-003286-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

802-247-09-032

Identifier Type: -

Identifier Source: org_study_id