Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
Public ClinicalTrials.gov record NCT01150097. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Extension Study to the Multicenter, Open-label, Randomized, Controlled Study CRAD001H2304 to Evaluate the Long-term Efficacy and Safety of Concentration-controlled Everolimus in Liver Transplant Recipient
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01150097
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 284 participants
Conditions and interventions
Conditions
Interventions
- Tacrolimus (reduced tacrolimus) Drug
- Everolimus (reduced tacrolimus) Drug
- Tacrolimus (tacrolimus elimination) Drug
- Everolimus (tacrolimus elimination) Drug
- Tacrolimus (tacrolimus control) Drug
- Corticosteroids Drug
Drug
Eligibility (public fields only)
- Age range
- 20 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 30, 2010
- Primary completion
- May 2, 2013
- Completion
- May 2, 2013
- Last update posted
- Nov 6, 2018
2010 – 2013
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Washington D.C. | District of Columbia | 20007-2197 | — |
| Novartis Investigative Site | Tampa | Florida | 33606 | — |
| Novartis Investigative Site | Lexington | Kentucky | 40536 | — |
| Novartis Investigative Site | Detroit | Michigan | 48202 | — |
| Novartis Investigative Site | Rochester | Minnesota | 55905 | — |
| Novartis Investigative Site | St Louis | Missouri | 63110 | — |
| Novartis Investigative Site | Newark | New Jersey | 07101 | — |
| Novartis Investigative Site | New York | New York | 10016 | — |
| Novartis Investigative Site | New York | New York | 10032 | — |
| Novartis Investigative Site | Chapel Hill | North Carolina | 27599 | — |
| Novartis Investigative Site | Durham | North Carolina | 27710 | — |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73112 | — |
| Novartis Investigative Site | Charleston | South Carolina | 29425 | — |
| Novartis Investigative Site | Houston | Texas | 77030-2400 | — |
| Novartis Investigative Site | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01150097, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 6, 2018 · Synced Sep 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01150097 live on ClinicalTrials.gov.