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 Biological: Placebo (Vehicle)	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 Wounds and Injuries

U.S. FDA Resources

Further study details as provided by Healthpoint:

Primary Outcome Measures:

The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. [ Time Frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first ] [ Designated as safety issue: No ]
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.

Secondary Outcome Measures:

Kaplan-Meier Probability of Non-Closure [ Time Frame: 14 weeks - the final visit for one subject was delayed by two weeks ] [ Designated as safety issue: No ]
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks. [ Time Frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first ] [ Designated as safety issue: No ]
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13 [ Time Frame: Over the 12 week treatment period or until the wound closed, which ever occurred first. ] [ Designated as safety issue: No ]
The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.
Proportion of Subjects With Complete Wound Closure at Each Visit [ Time Frame: Weekly, over the 12 week treatment period ] [ Designated as safety issue: No ]
Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.
Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain. [ Time Frame: Weekly, over the 12 week treatment period ] [ Designated as safety issue: No ]
Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.
Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline. [ Time Frame: 14 weeks - the final visit for one subject was delayed by two weeks ] [ Designated as safety issue: No ]
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.


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 Q7D Low dose HP802-247, applied at each visit	Biological: HP802-247 One dose of HP802-247 consists of 260 microliters (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 Q14D Low 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 microliters (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 Q7D High dose HP802-247, applied at each visit	Biological: HP802-247 One dose of HP802-247 consists of 260 microliters (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 Q14D 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 microliters (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 - Vehicle Placebo (Vehicle), applied at each visit	Biological: Placebo (Vehicle) Placebo (Vehicle) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received:	February 15, 2016
Last Updated:	February 15, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by Healthpoint:


Venous Leg Ulcer (VLU) Venous Stasis Ulcer (VSU) VLU	VSU Leg Ulcer Leg Wound

Additional relevant MeSH terms:


Ulcer Leg Ulcer Varicose Ulcer Postphlebitic Syndrome Postthrombotic Syndrome Pathologic Processes Skin Ulcer Skin Diseases Varicose Veins	Vascular Diseases Cardiovascular Diseases Phlebitis Peripheral Vascular Diseases Venous Insufficiency Venous Thrombosis Thrombosis Embolism and Thrombosis

ClinicalTrials.gov processed this record on September 27, 2016