Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents
NCT03703791 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2021-07-13
Summary
To compare the HRQOL of AR101 characterized oral desensitization immunotherapy (CODIT™) in combination with standard of care (peanut avoidance, education) versus standard of care alone in peanut-allergic subjects aged 4 to 17 years.
Conditions
Interventions
- BIOLOGICAL
-
AR101
AR101 powder
Sponsors & Collaborators
-
Aimmune Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Director of Regulatory Affairs · Aimmune Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 4 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-24
- Primary Completion
- 2018-11-23
- Completion
- 2018-11-23
- FDA Drug
- Yes
Countries
- Spain
Study Locations
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