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NIH/NIAID WITHDRAWAL FOR STABLE PEDIATRIC LIVER TRANSPLANT RECIPIENTS (iWITH)

Project: Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients (iWITH)

Sponsor: NIH/National Institute of Allergy and Infectious Diseases (NIAID)

Prime: University of California at San Francisco (Subcontractor: Rho)

Project Status: Active

Project Start: July 2012

Diseases: Pediatric Liver Transplant, Immunosuppression Withdrawal 

Objective: Anti-rejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent rejection of the new organ. Long-term use of these medicines put transplant recipients at higher risk of serious infections and certain types of cancer. The iWITH study seeks to do the following:

  • Find out if it is safe to slowly reduce and then completely stop the immunosuppression taken by children who have received liver transplants. This process is called “immunosuppression withdrawal” or ISW.
  • Find blood or liver biopsy tests that can help transplant doctors in the future predict if it is safe to decrease or stop immunosuppression drugs in children who have had a liver transplant.

Project Information: Rho serves as the Statistical and Data Coordinating Center for the 12-center pediatric liver transplant 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. 

Services:

  • Biostatistics and Statistical Programming
  • Clinical Data Management
  • Quality Assurance
  • Clinical Operations And Monitoring
  • Clinical Project Management
  • Product Safety and Pharmacovigilance Services
  • Study Document Management
  • Study Website Content Development and Maintenance