A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Angela Iheanacho, MS · STUDY_DIRECTOR · Abeona Therapeutics, Inc
- Sarah Abdelwahab, MD · STUDY_DIRECTOR · Abeona Therapeutics, Inc
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Wound Closure5 years
Proportion of RDEB wounds with healing ≥50%, ≥75%, and 100% at all clinic visits up to Month 54 as determined by direct investigator assessment.
- Pain Severity Scale (Wong-Baker FACES)5 years
Change in pain assessed by Wong-Baker FACES scale at all clinic visits up to Month 54. The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.
- Itch Severity Scale5 years
Longitudinal change of Itch severity scores assessed at all clinic visits up to Week 54. The minimum score value is 0 and the maximum score value is 10, with the higher scores being the worse outcome.
- Zarit Burden Interview Scale5 years
Longitudinal change of Zarit Burden Interview Short Form (ZBI-12) for caregiver scores related to wound care, assessed at all clinic visits up to Month 54. The minimum score value is 0 and the maximum score value is 4, with the higher scores being the worse outcome.
- Quality of Life in Epidermolysis Bullosa5 years
Quality of Life in Epidermolysis Bullosa (QOLEB) responses will be assessed at all clinic visits up to Month 54.
- Caregiver Global Impression of Change for Pain Scale5 years
Caregiver Global Impression of Change for Pain (CrGI-Pain) scores assessed at all clinic visits up to Month 54. The minimum score value is 1 and the maximum score value is 7, with the higher scores being the worse outcome.
- Wound Infection and Adverse Events5 years
The number of participants and wounds that have an infection or any related adverse event.
- The number of treatment-emergent adverse events.5 years
The number of treatment-emergent adverse events.
- Serious Adverse Events5 years
The number of participants and wounds that result in hospitalization (serious adverse event \[SAE\]).
- Incidence of squamous cell carcinoma.5 years
Incidence of squamous cell carcinoma.
- Replication-competent retrovirus (RCR) status5 years
Replication-competent retrovirus (RCR) status