NCT01638559

Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the efficacy of immunosuppression withdrawal (ISW) in pediatric liver transplant (tx) recipients.

Detailed description

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 places transplant recipients at higher risk of serious infections and certain types of cancer. This study seeks to: * 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 to predict if it is safe to decrease or stop immunosuppression drugs in children who have had a liver transplant.

Conditions

• Liver Transplant Recipients
• Liver Transplantation
• Immunosuppression

Interventions

Type	Name	Description
DRUG	Immunosuppression withdrawal	Participants will undergo gradual ISW in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants will be followed for 48 months ensuring a minimum of 36 months of follow-up after successful ISW.

Timeline

• Start date: 2012-08-14
• Primary completion: 2016-03-31
• Completion: 2018-06-11
• First posted: 2012-07-11
• Last updated: 2019-10-07
• Results posted: 2017-06-08

Locations

12 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study