Status:
COMPLETED
Individual Patient Exposure and Response in Pediatric Lupus
Lead Sponsor:
Duke University
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
5-17 years
Phase:
NA
Brief Summary
The purpose of this research study is to see if an electronic pill bottle cap can help children and teens with systemic lupus better remember to take their medicine. It will also gather information on...
Detailed Description
This is an exploratory Phase 2, single site, open-label, direct-to-family, adherence and exposure-response study of hydroxychloroquine (HCQ) in pediatric systemic lupus. The study will measure a parti...
Eligibility Criteria
Inclusion
- Signed and dated informed consent form and assent, when necessary
- Age 5-17.5 years at consent
- Enrolled in the CARRA Registry with a diagnosis of systemic lupus erythematosus as documented in the CARRA Registry
- Receiving hydroxychloroquine as standard of care for ≥ 3 months
- Participant and Caregiver primary language of English
- Willing and able to comply with study procedures, at the discretion of the study principal investigator
- Access to internet
Exclusion
- There are no pre-defined exclusion criterion for this trial.
Key Trial Info
Start Date :
September 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04358302
Start Date
September 28 2020
End Date
June 16 2021
Last Update
July 15 2024
Active Locations (1)
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1
Duke Clinical Research Institute
Durham, North Carolina, United States, 27701