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NCT00566488 · ClinicalTrials.gov registry record · Phase 1
Parathyroid and Thymus Transplantation in DiGeorge #931
A Phase 1 study, sponsored by Sumitomo Pharma Switzerland.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT00566488 is a Phase 1 study that has completed, run by Sumitomo Pharma Switzerland. The registered enrollment target is 25 participants.
The verdict
NCT00566488, a Phase 1 study, has completed, sponsored by Sumitomo Pharma Switzerland.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
This study has three primary purposes: to assess parathyroid function after parathyroid transplantation in infants with Complete DiGeorge syndrome; to assess immune function development after transplantation; and, to assess safety and tolerability of the procedures. This is a Phase 1, single site, open, non-randomized clinical protocol. Enrollment is closed and study intervention is complete for all enrolled subjects; but subjects continue for observation and follow-up. Subjects under 2 years old with complete DiGeorge syndrome (atypical or typical) received thymus transplantation. Subjects received pre-transplant immune suppression with rabbit anti-human-thymocyte-globulin. Subjects with hypoparathyroidism and an eligible parental donor received thymus and parental parathyroid transplantation. A primary hypothesis: Thymus/Parathyroid transplant subjects will need less calcium and/or calcitriol supplementation at 1 year post-transplant as compared to historical controls.
Interventions
- BIOLOGICAL Thymus/Parathyroid Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2005-01 |
| Est. Completion | 2019-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00566488
The ClinicalTrials.gov registry entry for NCT00566488 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma Switzerland, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Thymus/Parathyroid Transplantation is the first listed.
NCT00566488 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00566488 about?
NCT00566488 is a clinical study titled "Parathyroid and Thymus Transplantation in DiGeorge #931". This study has three primary purposes: to assess parathyroid function after parathyroid transplantation in infants with Complete DiGeorge syndrome; to assess immune function development after transplantation; and, to assess safety and tolerability of the procedures. This is a Phase 1, single site, o...
What is the current status of trial NCT00566488?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2005-01. Estimated completion is 2019-12.
What interventions are being tested in trial NCT00566488?
The interventions under investigation include: Thymus/Parathyroid Transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT00566488?
This trial is sponsored by Sumitomo Pharma Switzerland, which has 13 total clinical trials registered on ClinicalTrials.gov.
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