Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients

Completed · Phase 3

Conditions studied: Liver Transplant Recipient

In brief

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).

Key facts

Study ID

NCT01150097

Run by

Novartis Pharmaceuticals

People needed

284

Starts

2010-03-31

Expected to finish

2013-05-03

Last updated by the study team

2018-11-07

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent
• Ability and willingness to adhere to study regimen
• Completed core study with assigned regimen;

You may not qualify if…

• Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
• Severe hypercholesterolemia or hypertriglyceridemia.
• Low platelet count.
• Low white blood cell count.
• Positive test for human immunodeficiency virus (HIV).
• Systemic infection requiring active use of IV antibiotics.
• Patients in a critical care setting.
• Use of prohibited medication.
• Use of immunosuppressive agents not utilized in the protocol.
• Hypersensitivity to any of the study drugs or similar drugs.
• Pregnant or nursing (lactating) women
• Women of child-bearing potential not using a highly effective method of birth control.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Lexington, Kentucky, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — Rochester, Minnesota, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Newark, New Jersey, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Chapel Hill, North Carolina, United States
• Novartis Investigative Site — Durham, North Carolina, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — CABA, Buenos Aires, Argentina
• Novartis Investigative Site — San Martín, Buenos Aires, Argentina
• Novartis Investigative Site — Camperdown, New South Wales, Australia
• Novartis Investigative Site — Bedford Park, South Australia, Australia
• Novartis Investigative Site — Heidelberg, Victoria, Australia
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.