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

Venous Leg Ulcers Clinical Trial

— MOA 034  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02154087
• Other study ID #: 802-247-09-034
• Status: Terminated
• Phase: Phase 2
• First received: May 28, 2014
• Last updated: January 16, 2015
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2015
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 TNFa inhibitors

• History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcers

Intervention

Biological:
• HP802-247
260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine change from baseline in cell numbers in subjects with VLU following the first dose of HP802-247		5 weeks	No
Primary	= Determine change from baseline in cell types in subjects with VLU following the first dose of HP802-247		5 weeks	No
Primary	= Determine change from baseline in biochemical markers of inflammation in subjects with VLU following the first dose of HP802-247		5 weeks	No
Secondary	Wound closure, defined as complete re-epithelization with no drainage or need for a dressing, will be recorded as a secondary outcome measure following up to 12 weeks of dosing		12 weeks	No