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.
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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 31, 2010 (Actual)
- Primary completion
- May 3, 2013 (Actual)
- Completion
- May 3, 2013 (Actual)
- Last update posted
- Nov 7, 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 7, 2018 · Synced Nov 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01150097 live on ClinicalTrials.gov.