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

Purpose

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	Intervention	Phase
Venous Leg Ulcers	Biological: HP-802-247 Biological: Vehicle	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Leg Injuries and Disorders

Drug Information available for: Thrombin

U.S. FDA Resources

Further study details as provided by Healthpoint:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

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 ] [ Designated as safety issue: No ]
This key secondary outcome was based on a Cox Proportional Hazard Analysis and a Kaplan-Meier survival analysis.
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 ] [ Designated as safety issue: No ]
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.
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. ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
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.
Change in Target Ulcer Pain [ Time Frame: Weekly, over 12 week treament period, baseline ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
This key secondary outcome was based on a Kaplan-Meier survival analysis.


Enrollment:	447
Study Start Date:	August 2012
Study Completion Date:	December 2014
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656889

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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


Responsible Party:	Healthpoint
ClinicalTrials.gov Identifier:	NCT01656889 History of Changes
Other Study ID Numbers:	802-247-09-029
Study First Received:	August 1, 2012
Results First Received:	January 19, 2016
Last Updated:	February 16, 2016
Health Authority:	United States: Food and Drug Administration

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 Thrombin Hemostatics Coagulants

ClinicalTrials.gov processed this record on September 30, 2016