Clinical trial NCT02154087: A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
Official title: A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Venous Leg Ulcers
Keywords: Venous leg ulcer
Ulcer
Venous stasis
Compression
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2014-06-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247
timeFrame: Wound fluid samples were to be collected one week after the initial dose of HP802-247.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
state: Ohio
Study officials:
affiliation: Smith & Nephew Biotherapeutics; Chief Medical Officer
name: Herbert B Slade, MD
role: STUDY_CHAIR
References: