Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00622869 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 719
- Enrollment target
NCT00622869: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00622869 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 719 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00622869, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 719 participants
- Enrollment target
Study Summary
This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.
Primary Outcome
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 duct inflammation damage, venous endothelial inflammation) each scored on a scale of
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 | 719 participants |
| Start Date | 2008-01 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
What the finished NCT00622869 record still lists
NCT00622869 is an interventional study that assigns participants to a tested intervention. The registered 719 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Tacrolimus (reduced tacrolimus) is the first listed.
NCT00622869 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00622869 about?
NCT00622869 is a clinical study titled "Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients". This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.
What is the current status of trial NCT00622869?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 719 participants. The study started on 2008-01. Estimated completion is 2012-04.
What interventions are being tested in trial NCT00622869?
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 NCT00622869?
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 NCT00622869's enrollment target sits among peer trials
719 498th of 2000 higher than 1,503 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04916327 · 720 participants · NA
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1
- NCT05047224 · 720 participants · NA
Addressing Disparities in Autism Spectrum Disorder Diagnosis Using a Direct-to-home Telemedicine Tool
- NCT05309395 · 720 participants · Phase 3
Food Prescriptions to Promote Affordable Diets
- NCT05466214 · 720 participants · NA
Systematic Efficacy Replication Study of Conjoint Behavioral Consultation in Elementary Schools
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia