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

Healthpoint

Status and phase

Terminated

Phase 2

Conditions

Venous Leg Ulcers

Treatments

Biological: HP802-247

Study type

Interventional

Funder types

Industry

Identifiers

NCT02154087

802-247-09-034

Details and patient eligibility

About

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

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)