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

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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).


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
Caba, Buenos Aires
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Charleston, South Carolina 29407
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Charleston, SC
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Detroit, Michigan 48202
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Detroit, MI
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Durham, North Carolina 27710
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Durham, NC
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Houston, Texas 77030
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Houston, TX
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Lexington, Kentucky 40509
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Lexington, KY
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Newark, New Jersey 07103
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Newark, NJ
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Rochester, Minnesota 55905
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Rochester, MN
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Saint Louis, Missouri 63128
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Saint Louis, MO
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Tampa, Florida 33613
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Tampa, FL
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Washington, District of Columbia 20007
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Washington,
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