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

NCT02154087 | Terminated Phase 2 Results

• 1 other identifier: 802-247-09-034
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Venous Leg Ulcers

Keywords

Venous leg ulcer; Ulcer; Venous stasis; Compression

Outcome Measures

Primary Outcomes (1)

• Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247

  The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point \[i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3\]) and by subjects' quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3).

  Wound fluid samples were to be collected one week after the initial dose of HP802-247.

Study Arms (1)

HP802-247

EXPERIMENTAL

Biological: HP802-247

Interventions

HP802-247 BIOLOGICAL

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

HP802-247

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Healthpoint: lead

Study Sites (1)

Unknown Facility

Columbus, Ohio, 42305, United States

Location

MeSH Terms

Conditions

Varicose Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jaime E Dickerson, PhD
• Organization: Smith & Nephew, Inc

Jaime.Dickerson@smith-nephew.com

1-817-302-3914

Study Officials

• Herbert B Slade, MD

  Smith & Nephew Biotherapeutics; Chief Medical Officer

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 3, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 3, 2016
• Results First Posted: October 3, 2016

Record last verified: 2016-09

Locations

US (1)