By InvitationNot Applicable

A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB

United States22 participantsStarted 2021-02-09

Plain-language summary

A Long-Term Extension Study for Participants Previously Treated with EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Who can participate

Age range6 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Willing and able to give consent/assent; * If under the age of 18, guardian(s) is/are willing and able to give consent; * Prior study treatment with EB-101. Exclusion Criteria: * Inability to properly follow protocol as determined by the Principal Investigator

What they're measuring

Wound Closure

Timeframe: 5 years

Pain Reduction

Timeframe: 5 years

Itch Severity

Timeframe: 5 years

Zarit Burden Interview

Timeframe: 5 years

Quality of Life

Timeframe: 5 years

Caregiver Global impression of Pain

Timeframe: 5 years

Wound Infection and Adverse Events

Timeframe: 5 years

The number of treatment-emergent adverse events.

Timeframe: 5 years

Serious Adverse Events

Timeframe: 5 years

Trial details

NCT IDNCT05708677

SponsorAbeona Therapeutics, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2036-02

View on ClinicalTrials.gov More RDEB trials