Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2

NCT ID: NCT01737762

Last Updated: 2017-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-11-30

Brief Summary

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.

Detailed Description

This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 16-week treatment period. Vehicle looks the same as HP802-247 but contains no cells. Target wound status is evaluated at each study visit (closed, open, reopened). At wound closure or completion of treatment all subject will enter an observational safety followed up period which ends at one year after initial exposure to test article.

Conditions

Venous Leg Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HP802-247

HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.

Group Type: EXPERIMENTAL

HP802-247

Intervention Type: BIOLOGICAL

HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x106 cells per mL every 14 days.

Vehicle

Vehicle Control(fibrinogen solution \& thrombin solution without cells)

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: BIOLOGICAL

Interventions

HP802-247

HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x106 cells per mL every 14 days.

Intervention Type: BIOLOGICAL

Vehicle

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 >12 cm2 to ≤ 36 cm2
• 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 ≥ 6 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.
• 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.
• 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 autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
• History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
• Any prior exposure to HP802-247 or its vehicle.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Healthpoint

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert B Slade, MD

Role: STUDY_CHAIR

Healthpoint

Tommy Lee, MSHS

Role: STUDY_DIRECTOR

Healthpoint

Robert Kirsner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

William Marston, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

Phoenix, Arizona, United States

Phoenix, Arizona, United States

Phoenix, Arizona, United States

Carlsbad, California, United States

Castro Valley, California, United States

Fair Oaks, California, United States

Fresno, California, United States

Laguna Hills, California, United States

Long Beach, California, United States

Los Angeles, California, United States

San Diego, California, United States

Sylmar, California, United States

Washington D.C., District of Columbia, United States

Hialeah, Florida, United States

Miami, Florida, United States

South Miami, Florida, United States

Chicago, Illinois, United States

Jacksonville, Illinois, United States

Springfield, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Saginaw, Michigan, United States

Washington, Missouri, United States

Las Vegas, Nevada, United States

Bayonne, New Jersey, United States

Hoboken, New Jersey, United States

East Meadow, New York, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Akron, Ohio, United States

Willoughby, Ohio, United States

Tulsa, Oklahoma, United States

Dunmore, Pennsylvania, United States

Wyomissing, Pennsylvania, United States

Knoxville, Tennessee, United States

Fort Worth, Texas, United States

Tacoma, Washington, United States

Calgary, Alberta, Canada

Winnipeg, Manitoba, Canada

Hamilton, Ontario, Canada

London, Ontario, Canada

Sherbrooke, Quebec, Canada

San Juan, , Puerto Rico

Countries

United States; Canada; Puerto Rico

References

Marston WA, Ennis WJ, Lantis JC 2nd, Kirsner RS, Galiano RD, Vanscheidt W, Eming SA, Malka M, Cargill DI, Dickerson JE Jr, Slade HB; HP802-247 Study Group. Baseline factors affecting closure of venous leg ulcers. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):829-835.e1. doi: 10.1016/j.jvsv.2017.06.017.

Reference Type: DERIVED

PMID: 29037354 (View on PubMed)

Other Identifiers

802-247-09-031

Identifier Type: -

Identifier Source: org_study_id