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NCT01888432 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants
A Phase 3 study of Liver Transplantation, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 285
- Enrollment target
- 20
- Study locations
NCT01888432: Completed Phase 3 study of Liver Transplantation, sponsored by Novartis Pharmaceuticals.
NCT01888432 is a Phase 3 study of Liver Transplantation that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 285 participants, roughly in line with the 299-participant average among 12 other Liver Transplantation trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01888432, a Phase 3 study of Liver Transplantation, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 285 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
Primary Outcome
Rate of composite efficacy failure of treated biopsy proven acute rejection (tBPAR ≥ RAI score 3), graft loss (GL) or death (D) in everolimus with reduced tacrolimus group compared to standard tacrolimus at 12 months
Conditions Studied
Interventions
- DRUG Everolimus + reduced tacrolimus
- DRUG Standard tacrolimus
Study Locations (20)
Other
- Novartis Investigative Site - Cairo
- Novartis Investigative Site - Berlin
- Novartis Investigative Site - Jena
- Novartis Investigative Site - Kiel
California
- Novartis Investigative Site - Los Angeles
- Novartis Investigative Site - San Francisco
Massachusetts
- Novartis Investigative Site - Boston
- Novartis Investigative Site - Burlington
Tamil Nadu
- Novartis Investigative Site - Chennai
- Novartis Investigative Site - Chennai
Maryland
- Novartis Investigative Site - Baltimore
Michigan
- Novartis Investigative Site - Detroit
Minnesota
- Novartis Investigative Site - Minneapolis
New York
- Novartis Investigative Site - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2013-09-25 |
| Est. Completion | 2018-04-21 |
| Phase | Phase 3 |
What the finished NCT01888432 record still lists
NCT01888432 is an interventional study that assigns participants to a tested intervention. The registered 285 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 299-participant average among 12 other Liver Transplantation trials with a reported enrollment target.
The record links to 1 condition, with Liver Transplantation appearing as the primary indexed condition, and to 2 interventions - of which Everolimus + reduced tacrolimus is the first listed.
NCT01888432 names 20 study sites across 14 states, led by Other, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01888432 about?
NCT01888432 is a clinical study titled "Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants". The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
What is the current status of trial NCT01888432?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 285 participants. The study started on 2013-09-25. Estimated completion is 2018-04-21.
What conditions does trial NCT01888432 study?
This clinical trial studies the following conditions: Liver Transplantation.
What interventions are being tested in trial NCT01888432?
The interventions under investigation include: Everolimus + reduced tacrolimus (DRUG), Standard tacrolimus (DRUG).
Who is sponsoring clinical trial NCT01888432?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01888432 being conducted?
This trial has 20 study locations across California, Maryland, Massachusetts, Michigan, Minnesota. 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 NCT01888432's enrollment target sits among peer trials
285 4th of 12 higher than 9 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
-
Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
COMPLETED · Phase 3
-
Mediterranean Diet Post-liver Transplantation
RECRUITING · NA
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HOPE Against Cancer Recurrence in HCC
RECRUITING · Phase 4
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Reducing Pain With Methadone and Ketamine in Liver Transplant
RECRUITING · Phase 4
-
Immune Tolerance Induction After Liver Transplantation
RECRUITING · Phase 1
-
Sequential Hypo- and Normo-thermic Perfusion to Preserve Extended Criteria Donor Livers for Transplantation
ACTIVE NOT RECRUITING · NA
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