Status:
AVAILABLE
Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children
Lead Sponsor:
DBV Technologies
Conditions:
Peanut Allergy
Eligibility:
All Genders
2-17 years
Brief Summary
This is an open label expanded access program for male and female patients 2 years or older, to provide continued desensitization treatment with DBV712 250 mcg.
Detailed Description
This study is an open-label Expanded Access Protocol to provide continued treatment with DBV712 for individuals completing a DBV clinical study. Participation is by invitation according to the inclusi...
Eligibility Criteria
Inclusion
- Participation is by invitation, limited to individuals completing clinical study V712-303 (PEOPLE), previous Expanded Access Program or a DBV clinical study initiated after 31-Jan-2022
- Male and females; ages ≥ 2 years old at Visit 1 or current or prior studies.
- Negative urine pregnancy test for female participants of childbearing potential.
Exclusion
- Early withdrawal from a DBV712 clinical study.
- History of non-compliance during the primary clinical study or unable to follow the protocol requirements.
- Generalized dermatologic disease extending widely on the skin.
- History of intolerance or who developed hypersensitivity to excipients of the DBV712 patches.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05424731
Last Update
March 6 2023
Active Locations (1)
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1
Early Access Care, LLC
Madison, Connecticut, United States, 06443