Last updated: February 12, 2024
Sponsor: Organ, Tissue, Regeneration, Repair and Replacement
Overall Status: Active - Recruiting
Phase
N/A
Condition
Epidermolysis Bullosa
Pemphigus Vulgaris (Pv)
Treatment
Placebo
CACIPLIQ20
Clinical Study ID
NCT06007235
2022-A01774-39
Ages 3-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of Dystrophic or Junctional EB.
- 3 years ≤ age ≤ 18 years
- At least one active wound at inclusion
- Informed consent form signed by the patient's legal representative; if the patient isminor but capable of providing consent, additional signed consent from the patient.
- Patient and caregiver must be willing to comply with all protocol requirements.
Exclusion
Exclusion Criteria:
- Use of any investigational drug within the last 30 days before enrolment.
- Current or former malignancy.
- Pregnancy or breastfeeding during the study.
- Females of childbearing potential who are not abstinent and not practicing a medicallyacceptable method of contraception.
- Use of CACIPLIQ20 within the last 30 days before enrolment.
- Patients intolerant to one of the study device components or to heparinoids.
Study Design
Total Participants: 16
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
January 29, 2024
Estimated Completion Date:
September 30, 2024
Study Description
Connect with a study center
Hopital Necker - enfants malades
Paris, 75000
FranceActive - Recruiting
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