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Gentamicin in JEB Patients With Nonsense Mutations
NCT03526159Phase 2
Key facts
- Status
- Recruiting
- Start
- Jun 2018
- Primary completion
- Jul 2020
- Countries
- 1
- Sponsor
- University of Southern California
- Modality
- Nanoparticles, Implantable Devices, Transdermal Patches
- Drugs
- gentamicin
- Conditions
- junctional epidermolysis bullosa (JEB)
01
Overview
Phase 2, open-label trial of gentamicin in junctional epidermolysis bullosa (JEB) (2 arms), sponsored by University of Southern California. Primary endpoints: Increased laminin beta 3 / laminin 332 expression at 3 months, Incidence of Treatment-Emergent Adverse Events at 3 months and 1 more. Started Jun 2018; status: recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
IV Gentamicin
7.5 mg/kg gentamicin once daily for 14 days
Topical Gentamicin
0.5% gentamicin ointment applied twice daily for 14 days to selected skin sites
03
Who it enrols
JEB patients of any age with nonsense mutations in the LAMB3 gene, excluding those with pre-existing auditory or renal impairment, allergies to aminoglycosides/sulfates, or who are pregnant.
04
Endpoints
Primary
Increased laminin beta 3 / laminin 332 expression
Incidence of Treatment-Emergent Adverse Events
Generation of new hemidesmosomes
Secondary
Improved wound closure
Reduction in blistering
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