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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001815-21 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing.
It is hypothesized that ABH001 may initiate and continue wound healing in patients with epidermolysis bullosa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABH001 | Other | ABH001 application plus wound care dressings. |
|
| Control | Other | Control wound treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABH001 | Biological | ABH001 applications topically every 4 weeks (±1 week) with protocol-specified dressings until wound healed or up to 44 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in wound surface area | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in wound pain and wound itch | 24 weeks | |
| Patient global impression of change (PGIC) | 24 weeks | |
| Clinician global impression of change (CGIC) |
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Inclusion Criteria:
The subject or legal guardian must have read, understood and signed an Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent or Assent Form and must be able to and willing to follow study procedures and instructions
Male and female subjects.
Stable nutritional status.
Subjects with a confirmed diagnosis of generalized Epidermolysis Bullosa (EB)
Cutaneous wounds meeting the following criteria:
i. Two clinically non-infected cutaneous wounds with no clinically meaningful change in wound size during the observation period.
ii. Two matched wounds.
Negative urine pregnancy test for women of child-bearing potential.
Female subjects of childbearing potential and male subjects of procreative capacity must agree to use an effective method of contraception.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Arbuckle, MD, FAAD, FAAP | H&E Enterprises | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | United States | |||
| Lucile Packard Children's Hospital at Stanford University |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 14, 2014 | |
| Reset | Apr 17, 2014 | |
| Release | May 16, 2018 |
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| Control wound treatment | Other | 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 |
|
| 24 weeks |
| Proportion of subjects achieving reduction in wound surface area | 24 weeks |
| Time to reduction of wound surface area and duration of reduction | 24 weeks |
| Durability of wound healing | 24 weeks |
| Incidence, relatedness and severity of adverse events | Up to 48 Weeks |
| Redwood City |
| California |
| United States |
| Rady Children's Hospital - San Diego/UCSD, Pediatric and Adolescent Dermatology | San Diego | California | 92123 | United States |
| Denver Children's Hospital | Aurora | Colorado | 80045 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Virginia Clinical Research, Inc | Norfolk | Virginia | 23507 | United States |
| Landeskrankenhaus Salzburg-Universitätsklinikum der Paracelsus Medizinischen Privatuniversität | Salzburg | State of 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 |
| Reset | Jun 18, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2014 | Apr 17, 2014 | |||
| May 16, 2018 | Jun 18, 2018 |
| ID | Term |
|---|---|
| D004820 | Epidermolysis Bullosa |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012872 | Skin Diseases, Vesiculobullous |
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