A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HP802-247	HP802-247	-

Primary Outcome Measures

Name	Time	Method
Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247	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).

Secondary Outcome Measures