Trial Information
Biomarker-guided Withdrawal of Immunosuppression in Recipients of Vascularized Composite Tissue Transplants
Inclusion Criteria:
- adults who have received VCA transplants at Brigham and Women's Hospital
- no less than 3 months elapsed since VCA transplant,
- on steroid-free immune dual immunosuppression with tacrolimus (6-8 ng/ml trough
levels) and mycophenolate mofetil,
- no current concerns of rejection
Exclusion Criteria:
- recent (<3 months) episodes of rejection,
- active bacterial or viral infection,
- malignancy,
- non-healing wounds
- pregnancy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete cessation of immune suppression without evidence of rejection for more than 6 months.
Outcome Time Frame:
6 -24 months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
2012P001539
NCT ID:
NCT01853111
Start Date:
May 2013
Completion Date:
Related Keywords:
- Transplantation of Vascularized Composite Tissues Such as Face or Limbs