Trials / Recruiting
RecruitingNCT05329935
Congenital Athymia Patient Registry
Congenital Athymia Patient Registry of RETHYMIC
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 75 (estimated)
- Sponsor
- Sumitomo Pharma Switzerland GmbH · Industry
- Sex
- All
- Age
- 0 Years – 21 Years
- Healthy volunteers
- —
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).
Detailed 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). Currently, there is a single site where patients are being treated with RETHYMIC. The Investigator will be responsible for recruiting patients who have recently had (i.e., within the past 60 days) or are scheduled to have this treatment within 30 days and obtaining signed informed consent (and assent as applicable). The Investigator will collect baseline medical history and clinical data information for each enrolled subject. The start of follow-up (day 1) begins on the day following treatment surgery. Clinical data and flow cytometry test results (when conducted) will be abstracted from the medical records by Clinical Staff at baseline and during follow-up at predefined intervals.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Cultured Thymus Tissue | Product will be surgically administered into the quadriceps |
Timeline
- Start date
- 2022-05-25
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
- First posted
- 2022-04-15
- Last updated
- 2025-08-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05329935. Inclusion in this directory is not an endorsement.