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

Venous Leg Ulcers Clinical Trial

Official title:

A Phase 3 Randomized, Double Blind, Vehicle Controlled Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01737762
• Other study ID #: 802-247-09-031
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 20, 2012
• Last updated: November 13, 2014
• Start date: November 2012
• Est. completion date: May 2015

Study information

• Verified date: November 2014
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcers

Intervention

Biological:
• 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.
• Vehicle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Closure	Compare HP802-247 plus compression therapy against Vehicle plus compression therapy for proportion of subjects with complete wound closure over the 16-week treatment period from baseline.	16 Weeks	No
Secondary	Time in Days to Closure	Compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure, based on time in days to closure over the 16-week treatment period from baseline.	16 Weeks	No