Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01737762
First received: November 20, 2012
Last updated: November 13, 2014
Last verified: November 2014
  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:


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
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: NCT01737762

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85012
Phoenix, Arizona, United States, 85015
Phoenix, Arizona, United States, 85006
United States, California
Carlsbad, California, United States, 92009
Castro Valley, California, United States, 94546
Fair Oaks, California, United States, 95608
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
Sylmar, California, United States, 91342
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Hialeah, Florida, United States, 33013
Miami, Florida, United States, 33125
South Miami, Florida, United States, 33143
United States, Illinois
Chicago, Illinois, United States, 60611
Jacksonville, Illinois, United States, 62650
Springfield, Illinois, United States, 62702
United States, Maryland
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston, Massachusetts, United States, 02118
United States, Michigan
Saginaw, Michigan, United States, 48602
United States, Missouri
Washington, Missouri, United States, 63090
United States, Nevada
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Bayonne, New Jersey, United States, 07002
Hoboken, New Jersey, United States, 07030
United States, New York
Meadow, New York, United States, 11554
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
Willoughby, Ohio, United States, 44094
United States, Oklahoma
Tulsa, Oklahoma, United States, 74127
United States, Pennsylvania
Dunmore, Pennsylvania, United States, 18512
Wyomissing, Pennsylvania, United States, 19610
United States, Tennessee
Knoxville, Tennessee, United States, 37909
United States, Texas
Fort Worth, Texas, United States, 76107
United States, Washington
Tacoma, Washington, United States, 98431
Canada, Alberta
Calgary, Alberta, Canada, T2T5C7
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A1R9
Canada, Ontario
Hamilton, Ontario, Canada, L8R2R3
London, Ontario, Canada, N6C5J1
Canada, Quebec
Sherbrooke, Quebec, Canada, J1H5N4
Puerto Rico
San Juan, Puerto Rico, 00909-1711
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: November 13, 2014
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
Cardiovascular Diseases
Pathologic Processes
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014