NCT05329935|RecruitingFDA Drug
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Sponsor study identifier
observational
75
1 country
1
Study Start
May 25, 2022
Actual (reported)Primary Completion
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This Congenital Athymia Patient Registry is an observational exposure-based registry study. It uses a prospective cohort design to follow patients who have been treated with RETHYMIC. Clinical studies conducted with investigational RETHYMIC showed that treatment can result in immune reconstitution and prolong life. This treatment-based registry is being conducted to learn more about the reconstitution process following treatment and the impact of treatment on longer-term survival and the occurrence of adverse events of special interest (AESI).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 24, 2022
Actual (reported)April 15, 2022
Actual (reported)May 25, 2022
Actual (reported)April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Vital Status
12 months post treatment with RETHYMIC.
Flow cytometry including total and naïve CD3, CD4, and CD8 counts
Immediately after the intervention/procedure/surgery
AESI classified by MedDRA coding, severity and grade
Immediately after the intervention/procedure/surgery
All eligible patients
All eligible patients who survived 1 year post treatment
Product will be surgically administered into the quadriceps
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pediatric patients diagnosed with Congenital Athymia: • Who are scheduled for implantation with RETHYMIC within the next 30 days, or who were treated with RETHYMIC within the previous 60 days.
Duke University School of Medicine
Durham, North Carolina, 27710, United States
RETHYMIC US Prescribing Information, 2021.
First Submitted
March 24, 2022
First Posted
April 15, 2022
Study Start
May 25, 2022
Actual (reported)Primary Completion
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Parathyroid and Thymus Transplantation in DiGeorge #931
Contact the study team to confirm eligibility.
Study Completion
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 19, 2025
Record last verified: 2025-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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