| 1 |
NCT00576836 |
Active, not recruiting |
Thymus Transplantation Dose in DiGeorge #932 |
- DiGeorge Anomaly
- DiGeorge Syndrome
- Complete DiGeorge Anomaly
- Complete DiGeorge Syndrome
|
- Biological: Thymus Tissue for Transplantation
- Other: Parathyroid Tissue for Transplantation
|
Interventional
|
Phase 2 |
- M. Louise Markert
- National Institutes of Health (NIH)
- National Institute of Allergy and Infectious Diseases (NIAID)
- (and 3 more...)
|
Other / NIH / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Regression analyses used to correlate dose to immunologic parameters: T cell proliferative response; naïve T cells; and T cell variability.
- Thymus transplantation efficacy: survival is recorded. Immune reconstitution efficacy: T cell phenotypic and functional parameters are evaluated. This is evaluated in descriptive fashion.
- Parental parathyroid transplantation efficacy: number of subjects who are off calcium and calcitriol supplementation. The time that calcium supplementation needs to be resumed is recorded.
- (and 2 more...)
|
28 |
All |
Child, Adult, Older Adult |
NCT00576836 |
Pro00016144 #932
FDA-FD-R-002606
2R01AI047040-11A2
R56 Bridge R01AI4704011A1
5K12HD043494-09
R01AI054843
R01AI047040
3R56AI047040-11A1S1 |
|
February 2006 |
August 2010 |
June 2027 |
December 19, 2007 |
May 4, 2018 |
|
- Duke University Medical Center
Durham, North Carolina, United States
|
|
| 2 |
NCT00576407 |
Active, not recruiting |
Thymus Transplantation in DiGeorge Syndrome #668 |
- DiGeorge Syndrome
- Complete Typical DiGeorge Anomaly
|
- Biological: Thymus Tissue for Transplantation
|
Interventional
|
Phase 2 |
- M. Louise Markert
- National Institutes of Health (NIH)
- National Institute of Allergy and Infectious Diseases (NIAID)
- (and 3 more...)
|
Other / NIH / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Survival rate at one year post-transplantation.
- T cell proliferative response to tetanus toxoid
|
26 |
All |
Child, Adult, Older Adult |
NCT00576407 |
Pro00009955
2R01AI047040-11A2
R56 Bridge R01AI4704011A1
5K12HD043494-09
R01AI047040
3R56AI047040-11A1S1
R01AI054843
#668 |
|
November 2001 |
March 2008 |
June 2027 |
December 19, 2007 |
August 14, 2017 |
|
- Duke University Medical Center
Durham, North Carolina, United States
|
|
| 3 |
NCT02274662 |
Available |
Expanded Access Protocol Thymus Transplantation |
- Poor Thymic Function
- Immunodeficiency
- Athymia
- (and 3 more...)
|
- Biological: Thymus Transplantation
- Procedure: Blood Draw
- Drug: Rabbit Anti-Thymocyte Globulin and Cyclosporine or Tacrolimus
|
Expanded Access
|
|
- M. Louise Markert
- Enzyvant Therapeutics GmbH
- Duke University
|
Other / Industry |
|
|
|
All |
Child, Adult, Older Adult |
NCT02274662 |
Pro00051692 |
|
|
|
|
October 24, 2014 |
July 28, 2017 |
|
|
|
| 4 |
NCT01220531 |
Available |
Thymus Transplantation Safety-Efficacy |
- Complete DiGeorge Anomaly
- DiGeorge Syndrome
- DiGeorge Anomaly
- Complete DiGeorge Syndrome
|
- Biological: Thymus Tissue for Transplantation
- Procedure: Blood Draw
- Drug: Rabbit anti-thymocyte globulin
- (and 5 more...)
|
Expanded Access
- Intermediate-size Population
- Treatment IND/Protocol
|
|
- M. Louise Markert
- National Institutes of Health (NIH)
- National Institute of Allergy and Infectious Diseases (NIAID)
- (and 3 more...)
|
Other / NIH / Industry |
|
|
|
All |
Child, Adult, Older Adult |
NCT01220531 |
Pro00025966
2R01AI047040-11A2
5K12HD043494-09 |
|
|
|
|
October 14, 2010 |
May 21, 2018 |
|
- Duke University Medical Center
Durham, North Carolina, United States
|
|
| 5 |
NCT00566488 |
Active, not recruiting |
Parathyroid and Thymus Transplantation in DiGeorge #931 |
- DiGeorge Syndrome
- Hypoparathyroidism
- Complete DiGeorge Syndrome
|
- Biological: Thymus/Parathyroid Transplantation
|
Interventional
|
Phase 1 |
- M. Louise Markert
- Food and Drug Administration (FDA)
- National Institutes of Health (NIH)
- (and 4 more...)
|
Other / U.S. Fed / NIH / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Efficacy parameter: use of calcium/calcitriol at 1 year post-transplantation.
- Efficacy parameters: ionized calcium
- Efficacy parameters: CD3 count
- (and 7 more...)
|
25 |
All |
up to 24 Months (Child) |
NCT00566488 |
Pro00016482
R01AI047040
5K12HD043494-09
R01AI054843
FDA-FD-R-002606
2R01AI047040-11A2
R56 Bridge R01AI4704011A1
3R56AI047040-11A1S1
#931 |
|
January 2005 |
August 2007 |
June 2027 |
December 3, 2007 |
May 7, 2018 |
|
- Duke University Medical Center
Durham, North Carolina, United States
|
|
| 6 |
NCT00579709 |
Active, not recruiting |
Thymus Transplantation With Immunosuppression |
- DiGeorge Syndrome
- DiGeorge Anomaly
- Complete DiGeorge Anomaly
- Complete DiGeorge Syndrome
|
- Biological: Thymus Tissue for Transplantation
|
Interventional
|
Phase 1 |
- M. Louise Markert
- National Institutes of Health (NIH)
- National Institute of Allergy and Infectious Diseases (NIAID)
- (and 3 more...)
|
Other / NIH / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety & tolerability of Thymoglobulin and cyclosporine followed by thymus transplantation: Survival at 1 year post-transplantation.
- Use of additional post transplant immunosuppression after that listed in the protocol.
- Allograft biopsy used to evaluate graft rejection
- (and 6 more...)
|
15 |
All |
Child, Adult, Older Adult |
NCT00579709 |
Pro00013734
R01AI047040
R01AI054843
3R56AI047040-11A1S1
R56 Bridge R01AI4704011A1
2R01AI047040-11A2
5K12HD043494-09
#884 |
884 |
July 2002 |
December 2006 |
June 2027 |
December 24, 2007 |
July 28, 2017 |
|
- Duke University Medical Center
Durham, North Carolina, United States
|
|
| 7 |
NCT00579527 |
Active, not recruiting |
Phase I/II Thymus Transplantation With Immunosuppression #950 |
- DiGeorge Anomaly
- Complete DiGeorge Anomaly
- Complete Atypical DiGeorge Anomaly
- (and 2 more...)
|
- Biological: Thymus Tissue for Transplantation
- Other: Thymus Tissue and Parental Parathyroid Transplantation
- Procedure: Blood Draw
- (and 6 more...)
|
Interventional
|
Phase 1
Phase 2 |
- M. Louise Markert
- National Institutes of Health (NIH)
- National Institute of Allergy and Infectious Diseases (NIAID)
- (and 3 more...)
|
Other / NIH / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety/toxicity of 3 immunosuppression regimens in subjects undergoing thymus transplantation. Assessment will be survival at 1 year; incidence of fatal, severe, moderate, and disseminated infections; and, incidence of Grade 3 and 4 toxicities.
- Thymopoiesis: assessment will be done by evaluating thymus graft biopsy tissue post transplantation
- Development of T cell numbers and function post thymus transplantation using the 3 regimens tested.
- Efficacy of parental parathyroid transplantation. Number of subjects who are off both calcium and calcitriol supplementation. The time at which calcium supplementation needs to be resumed post parathyroid transplant will also be recorded.
|
28 |
All |
Child, Adult, Older Adult |
NCT00579527 |
Pro00011583
2R01AI047040-11A2
R56 Bridge R01AI4704011A1
5K12HD043494-09
R01AI047040
R01AI054843
#950 |
#950 |
March 2006 |
December 2011 |
June 2027 |
December 24, 2007 |
July 28, 2017 |
|
- Duke University Medical Center
Durham, North Carolina, United States
|
|
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