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
| City: |
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Oklahoma City |
| State: |
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Oklahoma |
| Zip Code: |
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73112 |
| Conditions: |
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Liver Transplant Recipient |
| Purpose: |
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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).
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01150097 |
| Primary Contact: |
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Study Director
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Phone: 862-778-8300
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| Backup Contact: |
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N/A |
| Location Contact: |
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Oklahoma City, Oklahoma 73112
United States
Novartis Pharmaceuticals
Phone: 862-778-8300
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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