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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.
ClinicalTrials.gov Identifier:
NCT01853384
First received: May 8, 2013
Last updated: November 18, 2014
Last verified: November 2014

May 8, 2013
November 18, 2014
November 2013
December 2015   (final data collection date for primary outcome measure)
Proportion of subjects with complete wound closure over the treatment period. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01853384 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers
A Phase 3 Randomized Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (EU)

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.

See Brief Summary

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Venous Ulcer
  • Venous Stasis Ulcer
  • Ulcer
  • 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.
  • 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
  • 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.
    Intervention: Biological: HP802-247
  • Placebo Comparator: HP802-247 Vehicle
    fibrinogen solution & thrombin solution without cells
    Intervention: Other: HP802-247 Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
440
February 2016
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Germany,   Hungary,   Poland
 
NCT01853384
802-247-09-032, 2012-003286-18
Yes
Smith & Nephew, Inc.
Smith & Nephew, Inc.
Not Provided
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
Smith & Nephew, Inc.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP