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Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients (iWITH)
Sponsored jointly by the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Immune Tolerance Network (ITN), the Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients (iWITH) study is a 12 center pediatric liver transplant study. The Principal Investigator for iWITH is Sandy Feng, MD, PhD, at the University of California at San Francisco. This study is designed to determine if it is safe to withdraw immunosuppression in children who have received liver transplants and to develop blood or liver biopsy tests that can help transplant doctors in the future to predict if it is safe to decrease or stop immunosuppression in individual children who have had a liver transplant.
Rho serves as the statistical and data coordinating center for the iWITH study. Our responsibilities encompass a broad range of functions including statistical design and analysis, clinical data collection, database storage and management, quality control, reporting and associated training for clinical site personnel, safety oversight, preparation of study-related materials, clinical monitoring, and clinical study Web site development and maintenance.
David Iklé (Ph.D., Senior Statistical Scientist) is the Principal Investigator for the iWITH coordinating center. Rho is also currently working with this same research team to develop another study evaluating the feasibility and safety of donor-reactive regulatory T cell therapy in pediatric liver transplant recipients.
For additional information, visit the posting on ClinicalTrials.gov.