Overview

This trial is active, not recruiting.

Conditions venous ulcer, venous stasis ulcer, ulcer
Treatments hp802-247, hp802-247 vehicle
Phase phase 3
Sponsor Smith & Nephew, Inc.
Start date November 2013
End date December 2015
Trial size 440 participants
Trial identifier NCT01853384, 2012-003286-18, 802-247-09-032

Summary

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.

At least 440 subjects will participate. The study is going to be conducted in approximately 5 countries at approximately 50 sites across the European Union.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
hp802-247
Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
(Placebo Comparator)
fibrinogen solution & thrombin solution without cells
hp802-247 vehicle Placebo
HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface. Subjects randomized to this intervention will receive applications weekly.

Primary Outcomes

Measure
Proportion of subjects with complete wound closure over the treatment period.
time frame: 12 Weeks

Secondary Outcomes

Measure
Time in days to complete wound closure from baseline over the 12 double-blind treatment weeks.
time frame: 12 Weeks
Proportion of subjects with complete wound closure at each of the 12 double-blind treatment weeks.
time frame: 12 weeks
Proportion of subjects with durable wound healing over the 3 months following complete wound closure.
time frame: 3 months
Pain associated with the target wound and target leg at each of the 12 double blind treatment weeks using the Visual Analog Scale (VAS).
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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 ≥ 2.0 cm2 and ≤ 12.0 cm2 - 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 ≥ 6 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. - 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. - 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 autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit. - History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers). - Any prior exposure to HP802-247 or its vehicle.

Additional Information

Official title A Phase 3 Randomized Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (EU)
Principal investigator Wolfgang Vanscheidt, Professor Dr
Description See Brief Summary
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Smith & Nephew, Inc..