Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers

Ulcer Clinical Trial

Official title:

A Phase 3 Randomized Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (EU)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01853384
• Other study ID #: 802-247-09-032
• Secondary ID: 2012-003286-18
• Status: Terminated
• Phase: Phase 3
• First received: May 8, 2013
• Last updated: July 10, 2015
• Start date: November 2013
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlGermany: Ethics CommissionGermany: Paul-Ehrlich-InstitutHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesHungary: Research Ethics Medical CommitteePoland: Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• 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 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.

At least 440 subjects will participate. The study is going to be conducted in approximately 5 countries at approximately 50 sites across the European Union.

Description:

See Brief Summary

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 252
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• 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 = 2.0 cm2 and = 12.0 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
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Ulcer
• Varicose Ulcer
• Venous Stasis Ulcer
• Venous Ulcer

Intervention

Biological:
• HP802-247
Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.

Other:
• HP802-247 Vehicle
HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Germany,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with complete wound closure over the treatment period.		12 Weeks	No
Secondary	Time in days to complete wound closure from baseline over the 12 double-blind treatment weeks.		12 Weeks	No
Secondary	Proportion of subjects with complete wound closure at each of the 12 double-blind treatment weeks.		12 weeks	No
Secondary	Proportion of subjects with durable wound healing over the 3 months following complete wound closure.		3 months	No
Secondary	Pain associated with the target wound and target leg at each of the 12 double blind treatment weeks using the Visual Analog Scale (VAS).		12 weeks	No