Dose Finding Study of HP802-247 in Venous Leg Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT00852995
First received: February 26, 2009
Last updated: September 19, 2013
Last verified: September 2013
  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:


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 Q14D
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 - 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
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

No publications provided by Healthpoint

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: September 19, 2013
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 October 19, 2014