Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers



Status:Completed
Conditions:Other Indications, Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2012
End Date:December 2014

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A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

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.


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.
We found this trial at
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