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

NCT ID: NCT02154087

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-10-31

Brief Summary

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

Conditions

Venous Leg Ulcers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HP802-247

Group Type: EXPERIMENTAL

HP802-247

Intervention Type: BIOLOGICAL

260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle

Interventions

HP802-247

260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle

Intervention Type: BIOLOGICAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Healthpoint

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert B Slade, MD

Role: STUDY_CHAIR

Smith & Nephew Biotherapeutics; Chief Medical Officer

Locations

Columbus, Ohio, United States

Countries

United States

Other Identifiers

802-247-09-034

Identifier Type: -

Identifier Source: org_study_id