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NCT00576836 · ClinicalTrials.gov registry record · Phase 2
Thymus Transplantation Dose in DiGeorge #932
A Phase 2 study of DiGeorge Syndrome and Complete DiGeorge Anomaly, sponsored by Sumitomo Pharma Switzerland.
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT00576836: Completed Phase 2 study of DiGeorge Syndrome and Complete DiGeorge Anomaly, sponsored by Sumitomo Pharma Switzerland.
NCT00576836 is a Phase 2 study of DiGeorge Syndrome and Complete DiGeorge Anomaly that has completed, run by Sumitomo Pharma Switzerland. The registered enrollment target is 7 participants, below the 451-participant average among 4 other DiGeorge Syndrome trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00576836, a Phase 2 study of DiGeorge Syndrome and Complete DiGeorge Anomaly, has completed, sponsored by Sumitomo Pharma Switzerland.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
One purpose of this study is to determine whether the amount of cultured thymus tissue implanted into DiGeorge anomaly infants has any effect on the immune outcome. Another purpose of this study is to determine whether parental parathyroid transplantation (in addition to cultured thymus tissue implantation (CTTI) can help both the immune and the calcium problems in DiGeorge infants with hypocalcemia. \[Funding Source - FDA Office of Orphan Products Development (OOPD)\]
Primary Outcome
Survival at 1 year post CTTI was assessed using the Kaplan Meier Estimated Survival. This mathematical function estimates the survival for a certain length of time.
Conditions Studied
Interventions
- BIOLOGICAL Cultured Thymus Tissue Implantation (CTTI)
- OTHER Cultured Thymus Tissue Implantation with Parathyroid Transplantation
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2004-09-02 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 2 |
What the finished NCT00576836 record still lists
NCT00576836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 451-participant average among 4 other DiGeorge Syndrome trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with DiGeorge Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Cultured Thymus Tissue Implantation (CTTI) is the first listed.
NCT00576836 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00576836 about?
NCT00576836 is a clinical study titled "Thymus Transplantation Dose in DiGeorge #932". One purpose of this study is to determine whether the amount of cultured thymus tissue implanted into DiGeorge anomaly infants has any effect on the immune outcome. Another purpose of this study is to determine whether parental parathyroid transplantation (in addition to cultured thymus tissue impla...
What is the current status of trial NCT00576836?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2004-09-02. Estimated completion is 2019-12-31.
What conditions does trial NCT00576836 study?
This clinical trial studies the following conditions: DiGeorge Syndrome, Complete DiGeorge Anomaly, Complete DiGeorge Syndrome, DiGeorge Anomaly.
What interventions are being tested in trial NCT00576836?
The interventions under investigation include: Cultured Thymus Tissue Implantation (CTTI) (BIOLOGICAL), Cultured Thymus Tissue Implantation with Parathyroid Transplantation (OTHER).
Who is sponsoring clinical trial NCT00576836?
This trial is sponsored by Sumitomo Pharma Switzerland, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00576836 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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