Status:
COMPLETED
Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Liver Transplant Recipient
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief 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 s...
Eligibility Criteria
Inclusion
- Written informed consent
- Ability and willingness to adhere to study regimen
- Completed core study with assigned regimen;
Exclusion
- 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
Key Trial Info
Start Date :
March 31 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2013
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT01150097
Start Date
March 31 2010
End Date
May 3 2013
Last Update
November 7 2018
Active Locations (57)
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1
Novartis Investigative Site
Washington D.C., District of Columbia, United States, 20007-2197
2
Novartis Investigative Site
Tampa, Florida, United States, 33606
3
Novartis Investigative Site
Lexington, Kentucky, United States, 40536
4
Novartis Investigative Site
Detroit, Michigan, United States, 48202