Dose Finding Study of HP802-247 in Venous Leg Ulcers - Full Text View

Purpose

This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.

Condition	Intervention	Phase
Venous Leg Ulcer Venous Stasis Ulcers	Biological: HP802-247	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers

Resource links provided by NLM:

MedlinePlus related topics: Leg Injuries and Disorders

U.S. FDA Resources

Further study details as provided by Healthpoint:

Primary Outcome Measures:

Percent of change from baseline in the target wound area [ Time Frame: 15 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse Events [ Time Frame: 15 Weeks ] [ Designated as safety issue: Yes ]

Enrollment:	228
Study Start Date:	February 2009
Study Completion Date:	July 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Low dose HP802-247, applied at each visit	Biological: HP802-247 One dose of HP802-247 consists of 260 uL containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
Experimental: B Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 1q2	Biological: HP802-247 One dose of HP802-247 consists of 260 uL containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
Experimental: C High dose HP802-247, applied at each visit	Biological: HP802-247 One dose of HP802-247 consists of 260 uL containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
Experimental: D High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12	Biological: HP802-247 One dose of HP802-247 consists of 260 uL containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
Placebo Comparator: E Placebo, applied at each visit	Biological: HP802-247 One dose of HP802-247 consists of 260 uL containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provide informed consent.
Willing to comply with protocol instructions, including allowing all study assessments.
Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the malleolus.
Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months.

Exclusion Criteria:

Women who are pregnant or lactating
Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
A target ulcer of non-venous etiologies.
Refusal of or inability to tolerate compression therapy.
Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit.
Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852995

Show 30 Study Locations

Sponsors and Collaborators

Healthpoint

Investigators

Study Chair:	Herbert B Slade, MD	Healthpoint
Principal Investigator:	William Marston, MD	University of North Carolina
Principal Investigator:	Robert Kirsner, MD	University of Miami
Principal Investigator:	Robert J Snyder, MD	Robert J Snyder

More Information

No publications provided by Healthpoint

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kirsner RS, Marston WA, Snyder RJ, Lee TD, Cargill DI, Slade HB. Spray-applied cell therapy with human allogeneic fibroblasts and keratinocytes for the treatment of chronic venous leg ulcers: a phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2012 Sep 15;380(9846):977-85. doi: 10.1016/S0140-6736(12)60644-8. Epub 2012 Aug 3.

Responsible Party:	Healthpoint
ClinicalTrials.gov Identifier:	NCT00852995 History of Changes
Other Study ID Numbers:	802-247-09-015
Study First Received:	February 26, 2009
Last Updated:	December 1, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Healthpoint:

Venous Leg Ulcer
Venous Stasis Ulcer
VLU

VSU
Leg Ulcer
Leg Wound

Additional relevant MeSH terms:

Leg Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Varicose Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Phlebitis
Peripheral Vascular Diseases

Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Varicose Veins
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013