A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers (MOA 034)

• ClinicalTrials.gov Identifier: NCT02154087
• Recruitment Status: Terminated
• First Posted: June 3, 2014
• Results First Posted: October 3, 2016
• Last Update Posted: October 3, 2016
• Sponsor: Healthpoint
• Information provided by (Responsible Party): Healthpoint

Study Description

Brief Summary:

Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers

Condition or disease	Intervention/treatment	Phase
Venous Leg Ulcers	Biological: HP802-247	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
• Study Start Date: July 2014
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: HP802-247	Biological: HP802-247; 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle

Outcome Measures

Primary Outcome Measures :

1. Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247 [ Time Frame: Wound fluid samples were to be collected one week after the initial 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, Ohio

Columbus, Ohio, United States, 42305

Sponsors and Collaborators

Healthpoint

Investigators

• Study Chair: Herbert B Slade, MD; Smith & Nephew Biotherapeutics; Chief Medical Officer

More Information

• Responsible Party: Healthpoint
• ClinicalTrials.gov Identifier: NCT02154087
• Other Study ID Numbers: 802-247-09-034
• First Posted: June 3, 2014
• Results First Posted: October 3, 2016
• Last Update Posted: October 3, 2016
• Last Verified: September 2016

Keywords provided by Healthpoint:

Venous leg ulcer; Ulcer; Venous stasis; Compression

Additional relevant MeSH terms:

Varicose Ulcer; Leg Ulcer; Ulcer; Pathologic Processes; Skin Ulcer; Skin Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases