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NCT01150097 · ClinicalTrials.gov registry record · Phase 3
Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 284
- Enrollment target
NCT01150097: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01150097 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 284 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01150097, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 284 participants
- Enrollment target
Study Summary
The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).
Primary Outcome
The number of participants who experienced composite efficacy failure was analyzed. Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile
Interventions
- DRUG Tacrolimus (reduced tacrolimus)
- DRUG Everolimus (reduced tacrolimus)
- DRUG Tacrolimus (tacrolimus elimination)
- DRUG Everolimus (tacrolimus elimination)
- DRUG Tacrolimus (tacrolimus control)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 284 participants |
| Start Date | 2010-03-31 |
| Est. Completion | 2013-05-03 |
| Phase | Phase 3 |
What the finished NCT01150097 record still lists
NCT01150097 is an interventional study that assigns participants to a tested intervention. The registered 284 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 5 interventions - of which Tacrolimus (reduced tacrolimus) is the first listed.
NCT01150097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01150097 about?
NCT01150097 is a clinical study titled "Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients". The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosi...
What is the current status of trial NCT01150097?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 284 participants. The study started on 2010-03-31. Estimated completion is 2013-05-03.
What interventions are being tested in trial NCT01150097?
The interventions under investigation include: Tacrolimus (reduced tacrolimus) (DRUG), Everolimus (reduced tacrolimus) (DRUG), Tacrolimus (tacrolimus elimination) (DRUG), Everolimus (tacrolimus elimination) (DRUG), Tacrolimus (tacrolimus control) (DRUG).
Who is sponsoring clinical trial NCT01150097?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01150097's enrollment target sits among peer trials
284 1189th of 2000 higher than 807 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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