RECRUITING

Congenital Athymia Patient Registry

Description

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).

Study Overview

Study Details

Study overview

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).

Congenital Athymia Patient Registry of RETHYMIC

Congenital Athymia Patient Registry

Condition
Complete DiGeorge Anomaly
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University School of Medicine, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Written informed consent cannot be obtained.

Ages Eligible for Study

0 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sumitomo Pharma Switzerland GmbH,

Study Record Dates

2026-04