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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

November 20, 2012
November 13, 2014
November 2012
April 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01737762 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
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

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.

Not Provided
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 Leg Ulcers
  • 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.
  • Biological: Vehicle
  • 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.
    Intervention: Biological: HP802-247
  • Placebo Comparator: Vehicle
    Vehicle Control(fibrinogen solution & thrombin solution without cells)
    Intervention: Biological: 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
250
May 2015
April 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 >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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Puerto Rico
 
NCT01737762
802-247-09-031
Yes
Healthpoint
Healthpoint
Not Provided
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
Healthpoint
November 2014

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