Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 20 - 75 |
Updated: | 11/9/2018 |
Start Date: | March 31, 2010 |
End Date: | May 3, 2013 |
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
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).
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).
Inclusion Criteria:
- Written informed consent
- Ability and willingness to adhere to study regimen
- Completed core study with assigned regimen;
Exclusion Criteria:
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
We found this trial at
14
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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