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 range

6 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Trial details

NCT IDNCT05708677

SponsorAbeona Therapeutics, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2036-02

View on ClinicalTrials.gov More RDEB trials

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

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

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