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

June 27, 2017 updated by: Healthpoint

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).

At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.

Study Overview

Status

Completed

Conditions

Detailed Description

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. Target wound status is evaluated at each study visit (closed, open, reopened). At wound closure or completion of treatment all subject will enter an observational safety followed up period which ends at one year after initial exposure to test article.

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2T5C7
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A1R9
    • Ontario
      • Hamilton, Ontario, Canada, L8R2R3
      • London, Ontario, Canada, N6C5J1
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H5N4
      • San Juan, Puerto Rico, 00909-1711
    • Arizona
      • Phoenix, Arizona, United States, 85012
      • Phoenix, Arizona, United States, 85015
      • Phoenix, Arizona, United States, 85006
    • 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
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20007
    • Florida
      • Hialeah, Florida, United States, 33013
      • Miami, Florida, United States, 33125
      • South Miami, Florida, United States, 33143
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Jacksonville, Illinois, United States, 62650
      • Springfield, Illinois, United States, 62702
    • Maryland
      • Baltimore, Maryland, United States, 21224
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
    • Michigan
      • Saginaw, Michigan, United States, 48602
    • Missouri
      • Washington, Missouri, United States, 63090
    • Nevada
      • Las Vegas, Nevada, United States, 89119
    • New Jersey
      • Bayonne, New Jersey, United States, 07002
      • Hoboken, New Jersey, United States, 07030
    • New York
      • East Meadow, New York, United States, 11554
      • New York, New York, United States, 10025
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
    • Ohio
      • Akron, Ohio, United States, 44307
      • Willoughby, Ohio, United States, 44094
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74127
    • Pennsylvania
      • Dunmore, Pennsylvania, United States, 18512
      • Wyomissing, Pennsylvania, United States, 19610
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
    • Texas
      • Fort Worth, Texas, United States, 76107
    • Washington
      • Tacoma, Washington, United States, 98431

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Closure
Time Frame: 16 Weeks
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.
16 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in Days to Closure
Time Frame: 16 Weeks
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.
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: William Marston, MD, University of North Carolina
  • Principal Investigator: Robert Kirsner, MD, University of Miami
  • Study Director: Tommy Lee, MSHS, Healthpoint

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

November 20, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results summaries have been sent to each site for distribution to participants

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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