A Study of the Efficacy and Safety of ABH001 in the Treatment of Patients With Epidermolysis Bullosa Who Have Wounds That Are Not Healing
NCT ID: NCT01749306
Last Updated: 2013-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
1 participants
INTERVENTIONAL
2012-12-31
2013-11-30
Brief Summary
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It is hypothesized that ABH001 may initiate and continue wound healing in patients with epidermolysis bullosa.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ABH001
ABH001 application plus wound care dressings.
ABH001
ABH001 applications topically every 4 weeks (±1 week) with protocol-specified dressings until wound healed or up to 44 weeks
Control
Control wound treatment
Control wound treatment
Control wound care with protocol-specified dressings every 4 weeks (±1 week) up to 20 weeks with optional cross-over to ABH001 for additional 20 weeks
Interventions
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ABH001
ABH001 applications topically every 4 weeks (±1 week) with protocol-specified dressings until wound healed or up to 44 weeks
Control wound treatment
Control wound care with protocol-specified dressings every 4 weeks (±1 week) up to 20 weeks with optional cross-over to ABH001 for additional 20 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male and female subjects.
3. Stable nutritional status.
4. Subjects with a confirmed diagnosis of generalized Epidermolysis Bullosa (EB)
5. Cutaneous wounds meeting the following criteria:
1. Anatomical location: arms, legs, thorax, or back above the waistline and below the neck.
2. Documented age (duration) of the wound(s).
3. One or more wounds capable of potentially meeting the following wound selection criteria at the end of the observation period:
i. Two clinically non-infected cutaneous wounds with no clinically meaningful change in wound size during the observation period.
ii. Two matched wounds.
6. Negative urine pregnancy test for women of child-bearing potential.
7. Female subjects of childbearing potential and male subjects of procreative capacity must agree to use an effective method of contraception.
Exclusion Criteria
2. Diagnosis of non-genetic generalized EB.
3. Localized, active clinical infection of study wounds.
4. Diseases or conditions that could interfere with the assessment of safety and efficacy of the study treatment and compliance of the subject with study visits/procedures.
5. Known allergy to bovine products.
6. Known allergy to silver products.
7. Systemic infection at the time of enrolment in the study.
8. Currently receiving or have received oral steroid therapy within the previous 4 weeks.
9. Taking, or have participated in other clinical studies involving gene therapy, stem cell therapy, recombinant DNA/protein therapy.
10. Received ABH001, or other biologic or cell therapy for the treatment of EB in the study wound sites within the previous 3 months.
11. Hypersensitivity to any of the therapeutic agents.
12. History of malignant skin disease.
ALL
No
Sponsors
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Shire Regenerative Medicine, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alan Arbuckle, MD, FAAD, FAAP
Role: PRINCIPAL_INVESTIGATOR
H&E Enterprises
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Lucile Packard Children's Hospital at Stanford University
Redwood City, California, United States
Rady Children's Hospital - San Diego/UCSD, Pediatric and Adolescent Dermatology
San Diego, California, United States
Denver Children's Hospital
Aurora, Colorado, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, United States
Landeskrankenhaus Salzburg-Universitätsklinikum der Paracelsus Medizinischen Privatuniversität
Salzburg, Salzburg, Austria
Toronto Regional Wound Healing Clinic
Mississauga, Ontario, Canada
University of Montreal
Montreal, Quebec, Canada
Hôpital Necker-Enfants Malades
Paris, Île-de-France Region, France
University of Freiburg (Studiensekretariat Hautklinik Universitätsklinikum Freiburg - Hautklinik)
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Warszawki Uniwersytet Medyczny Katedra I Klinika Dermatologiczna
Warsaw, Masovian Voivodeship, Poland
Hospital CUF Descobertas
Lisbon, Lisbon District, Portugal
Hospital Universitario La Paz
Madrid, Madrid, Spain
Countries
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Other Identifiers
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2012-001815-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EB01-ABH001
Identifier Type: -
Identifier Source: org_study_id