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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Smith & Nephew, Inc.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01853384
First received: May 8, 2013
Last updated: August 8, 2014
Last verified: August 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.

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.


Condition Intervention Phase
Venous Ulcer
Venous Stasis Ulcer
Ulcer
Biological: HP802-247
Other: HP802-247 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 Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (EU)

Resource links provided by NLM:


Further study details as provided by Smith & Nephew, Inc.:

Primary Outcome Measures:
  • Proportion of subjects with complete wound closure over the treatment period. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time in days to complete wound closure from baseline over the 12 double-blind treatment weeks. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with complete wound closure at each of the 12 double-blind treatment weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with durable wound healing over the 3 months following complete wound closure. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Pain associated with the target wound and target leg at each of the 12 double blind treatment weeks using the Visual Analog Scale (VAS). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: November 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 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 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
Biological: 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. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
Placebo Comparator: HP802-247 Vehicle
fibrinogen solution & thrombin solution without cells
Other: 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. Subjects randomized to this intervention will receive applications weekly.
Other Name: Placebo

Detailed Description:

See Brief Summary

  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: NCT01853384

Contacts
Contact: Tommy Lee, MSHS 800-441-8227

  Show 49 Study Locations
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
Study Chair: Herbert B. Slade, MD Smith & Nephew, Inc.
Study Director: Tommy Lee, MSHS Smith & Nephew, Inc.
Principal Investigator: Wolfgang Vanscheidt, Professor Dr University Freiburg-Practice for Dermatology
  More Information

No publications provided

Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01853384     History of Changes
Other Study ID Numbers: 802-247-09-032, 2012-003286-18
Study First Received: May 8, 2013
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Germany: Ethics Commission
Germany: Paul-Ehrlich-Institut
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Hungary: Research Ethics Medical Committee
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Smith & Nephew, Inc.:
deep vein thrombosis
Venous leg ulcer
ulcer
venous stasis
compression
venous
venous stasis ulcer
vlu
wound
varicose veins
venous insufficiency
dvt

Additional relevant MeSH terms:
Leg Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Varicose Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Varicose Veins
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014