Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2 - 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 16-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.

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

Condition	Intervention	Phase
Venous Leg Ulcers	Biological: HP802-247 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 >12 cm2 to ≤ 36 cm2

Resource links provided by NLM:

MedlinePlus related topics: Leg Injuries and Disorders Varicose Veins

U.S. FDA Resources

Further study details as provided by Healthpoint:

Primary Outcome Measures:

Wound Closure [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Time in Days to Closure [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
Compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure, based on time in days to closure over the 16-week treatment period from baseline.

Estimated Enrollment:	250
Study Start Date:	November 2012
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	April 2015 (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 solution) containing 0.5 x 106 cells per mL every 14 days.	Biological: 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 x106 cells per mL every 14 days.
Placebo Comparator: Vehicle Vehicle Control(fibrinogen solution & thrombin solution without cells)	Biological: Vehicle

Eligibility

Ages Eligible for Study:	18 Years and older
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 >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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737762

Contacts

Contact: Nick D McCoy, `BS

817-302-3924

nick.mccoy@healthpoint.com

Show 39 Study Locations

Sponsors and Collaborators

Healthpoint

Investigators

Study Chair:	Herbert B Slade, MD	Healthpoint
Study Director:	Tommy Lee, MSHS	Healthpoint
Principal Investigator:	Robert Kirsner, MD	University of Miami
Principal Investigator:	William Marston, MD	University of North Carolina

More Information

No publications provided

Responsible Party:	Healthpoint
ClinicalTrials.gov Identifier:	NCT01737762 History of Changes
Other Study ID Numbers:	802-247-09-031
Study First Received:	November 20, 2012
Last Updated:	February 14, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Healthpoint:

Venous leg ulcer
ulcer
Venous stasis
compression
venous
venous stasis ulcer

vlu
wound
varicose veins
venous insufficiency
dvt
deep vein thrombosis

Additional relevant MeSH terms:

Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases

Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013