Back to resultsA Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers (MOA 034)
Primary Purpose
Venous Leg Ulcers
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HP802-247
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
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 ≥ 4.0 cm x cm and ≤ 15.0 cm x cm
- 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 ≥ 12 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 or any other component of HP802-247,or known sensitivity to Iodine
- 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, or any participation in a previous HP802-247 trial
- 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 Collagenase Santyl® ointment, autologous skin graft, biological dressings or living cell products (e.g., Oasis®, Apligraf™, Dermagraft™) within 30 days preceding the Screening Visit
- Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit
- Current therapy with systemic antibiotics
- Current systemic therapy with cytotoxic drugs
- Current therapy with chronic (> 10 days) oral corticosteroids
- Current therapy with TNFα inhibitors
- History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HP802-247
Arm Description
Outcomes
Primary Outcome Measures
Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247
The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point [i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3]) and by subjects' quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02154087
Brief Title
A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
Acronym
MOA 034
Official Title
A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
based on outcome of previous study
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthpoint
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HP802-247
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
HP802-247
Intervention Description
260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle
Primary Outcome Measure Information:
Title
Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247
Description
The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point [i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3]) and by subjects' quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3).
Time Frame
Wound fluid samples were to be collected one week after the initial dose of HP802-247.
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 ≥ 4.0 cm x cm and ≤ 15.0 cm x cm
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 ≥ 12 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 or any other component of HP802-247,or known sensitivity to Iodine
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, or any participation in a previous HP802-247 trial
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 Collagenase Santyl® ointment, autologous skin graft, biological dressings or living cell products (e.g., Oasis®, Apligraf™, Dermagraft™) within 30 days preceding the Screening Visit
Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit
Current therapy with systemic antibiotics
Current systemic therapy with cytotoxic drugs
Current therapy with chronic (> 10 days) oral corticosteroids
Current therapy with TNFα inhibitors
History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert B Slade, MD
Organizational Affiliation
Smith & Nephew Biotherapeutics; Chief Medical Officer
Official's Role
Study Chair
Facility Information:
City
Columbus
State/Province
Ohio
ZIP/Postal Code
42305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
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