Congenital Athymia Patient Registry of RETHYMIC

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Maximum Age: 21
View:

• 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.

⁃ Who have provided written informed consent directly, or written informed consent has been provided by the patient, the parent, or legal guardian.

Locations
United States
North Carolina
Duke University School of Medicine
RECRUITING
Durham
Contact Information
Primary
John Sleasman, M.D.
john.sleasman@duke.edu
919-684-9914
Time Frame
Start Date: 2022-05-25
Estimated Completion Date: 2026-04
Participants
Target number of participants: 75
Treatments
Main cohort
All eligible patients
Secondary cohort
All eligible patients who survived 1 year post treatment
Sponsors
Leads: Sumitomo Pharma Switzerland GmbH

This content was sourced from clinicaltrials.gov

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