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NCT01638559 · ClinicalTrials.gov registry record · Phase 2
Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients
A Phase 2 study of Liver Transplantation and Immunosuppression, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 161
- Enrollment target
- 12
- Study locations
NCT01638559: Completed Phase 2 study of Liver Transplantation and Immunosuppression, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01638559 is a Phase 2 study of Liver Transplantation and Immunosuppression that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 161 participants, below the 310-participant average among 12 other Liver Transplantation trials with a reported enrollment target (48% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01638559, a Phase 2 study of Liver Transplantation and Immunosuppression, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 161 participants
- Enrollment target
- 12
- Study locations
Study Summary
The primary objective of this study is to assess the efficacy of immunosuppression withdrawal (ISW) in pediatric liver transplant (tx) recipients.
Primary Outcome
Number of participants that are operationally tolerant, defined as those who successfully withdraw from immunosuppression and maintain normal allograft status as assessed by liver biopsy and liver tests 12 months after complete immunosuppression withdrawal.
Conditions Studied
Interventions
- DRUG Immunosuppression withdrawal
Study Locations (12)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh - Pittsburgh
California
- University of California - San Francisco
Colorado
- Children's Hospital of Colorado - Aurora
Georgia
- Emory University and Children's Hospital of Atlanta - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Michigan
- University of Michigan C. S. Mott Children's Hospital - Ann Arbor
Missouri
- St. Louis Children's Hospital - Washington University - St Louis
New York
- New York Presbyterian Morgan Stanley Children's Hospital - Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2012-08-14 |
| Est. Completion | 2018-06-11 |
| Phase | Phase 2 |
What the finished NCT01638559 record still lists
NCT01638559 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, below the 310-participant average among 12 other Liver Transplantation trials with a reported enrollment target (48% lower).
The record links to 3 conditions, with Liver Transplantation appearing as the primary indexed condition, and to 1 intervention - of which Immunosuppression withdrawal is the first listed.
NCT01638559 lists 12 locations in 11 states (Pennsylvania, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT01638559 about?
NCT01638559 is a clinical study titled "Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients". The primary objective of this study is to assess the efficacy of immunosuppression withdrawal (ISW) in pediatric liver transplant (tx) recipients.
What is the current status of trial NCT01638559?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 161 participants. The study started on 2012-08-14. Estimated completion is 2018-06-11.
What conditions does trial NCT01638559 study?
This clinical trial studies the following conditions: Liver Transplantation, Immunosuppression, Liver Transplant Recipients.
What interventions are being tested in trial NCT01638559?
The interventions under investigation include: Immunosuppression withdrawal (DRUG).
Who is sponsoring clinical trial NCT01638559?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01638559 being conducted?
This trial has 12 study locations across California, Colorado, Georgia, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Liver Transplantation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01638559's enrollment target sits among peer trials
161 6th of 12 higher than 7 of 12 other Liver Transplantation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Liver Transplantation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Mediterranean Diet Post-liver Transplantation
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-
HOPE Against Cancer Recurrence in HCC
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Sequential Hypo- and Normo-thermic Perfusion to Preserve Extended Criteria Donor Livers for Transplantation
ACTIVE NOT RECRUITING · NA
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Molecular Assessment and Profiling of Liver Transplant Recipients
ACTIVE NOT RECRUITING
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