Back to resultsStudy Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
Primary Purpose
Venous Leg Ulcers
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HP802-247
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcers focused on measuring Venous leg ulcer, ulcer, Venous stasis, compression, venous, venous stasis ulcer, vlu, wound, varicose veins, venous insufficiency, dvt, deep vein thrombosis
Eligibility 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 >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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HP802-247
Vehicle
Arm Description
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.
Vehicle Control(fibrinogen solution & thrombin solution without cells)
Outcomes
Primary Outcome Measures
Wound Closure
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.
Secondary Outcome Measures
Time in Days to Closure
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01737762
Brief Title
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
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 >12 cm2 to ≤ 36 cm2
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthpoint
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcers
Keywords
Venous leg ulcer, ulcer, Venous stasis, compression, venous, venous stasis ulcer, vlu, wound, varicose veins, venous insufficiency, dvt, deep vein thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HP802-247
Arm Type
Experimental
Arm Description
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.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle Control(fibrinogen solution & thrombin solution without cells)
Intervention Type
Biological
Intervention Name(s)
HP802-247
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Vehicle
Primary Outcome Measure Information:
Title
Wound Closure
Description
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.
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Time in Days to Closure
Description
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.
Time Frame
16 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 >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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert B Slade, MD
Organizational Affiliation
Healthpoint
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tommy Lee, MSHS
Organizational Affiliation
Healthpoint
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert Kirsner, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Marston, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92013
Country
United States
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Jacksonville
State/Province
Illinois
ZIP/Postal Code
62650
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
City
Bayonne
State/Province
New Jersey
ZIP/Postal Code
07002
Country
United States
City
Hoboken
State/Province
New Jersey
ZIP/Postal Code
07030
Country
United States
City
East Meadow
State/Province
New York
ZIP/Postal Code
11554
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74127
Country
United States
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2T5C7
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A1R9
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8R2R3
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6C5J1
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
City
San Juan
ZIP/Postal Code
00909-1711
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Results summaries have been sent to each site for distribution to participants
Citations:
PubMed Identifier
29037354
Citation
Marston WA, Ennis WJ, Lantis JC 2nd, Kirsner RS, Galiano RD, Vanscheidt W, Eming SA, Malka M, Cargill DI, Dickerson JE Jr, Slade HB; HP802-247 Study Group. Baseline factors affecting closure of venous leg ulcers. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):829-835.e1. doi: 10.1016/j.jvsv.2017.06.017.
Results Reference
derived
Learn more about this trial
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
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