Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT06834035
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations.
2. Diagnosis of EBA demonstrated by the presence of levels of serum C7 antibodies above the normal ELISA range
3. Baseline skin blistering greater than 5% total body surface area
4. 1 wound at least 20 cm\^2 able to be entirely treated with Vyjuvek weekly
5. 1 wound at least 20 cm\^2 that has never been treated with Vyjuvek
6. Ongoing VYJUVEK treatment.
Exclusion Criteria:
1. History of thrombotic event(s)
2. History of cardiac failure
3. History of renal failure
4. IgA deficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT06834035
Study Brief:
Protocol Section:
NCT06834035