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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01656889
First received: August 1, 2012
Last updated: April 18, 2014
Last verified: April 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 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:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Wound Closure [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Event [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 440
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 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

  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 ≥ 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

  Show 50 Study Locations
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

No publications provided

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01656889     History of Changes
Other Study ID Numbers: 802-247-09-029
Study First Received: August 1, 2012
Last Updated: April 18, 2014
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:
Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014