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
Phase 3
20 Years
72 Years
20 Years
72 Years
Open (Enrolling)
Both
Liver Transplant Recipient
Both
Liver Transplant Recipient
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Assessment of renal function by Estimated Glomerular Filtration Rate. Efficacy failure as treated biopsy proven acute rejection (BPAR ), graft loss or death. Rate of progression of HCV related allograft fibrosis
Outcome Time Frame:
at 36 and 48 months post-transplantation
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CRAD001H2304E1
NCT ID:
NCT01150097
Start Date:
April 2010
Completion Date:
Related Keywords:
- Liver Transplant Recipient
- Liver transplantation
- Everolimus
- Calcineurin inhibitors
- Tacrolimus
- Renal function
- Progression of HCV related allograft fibrosis
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| UCSF | San Francisco, California 941430324 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| Cedars-Sinai Medical Center | Los Angeles, California 90048 |
| Piedmont Hospital | Atlanta, Georgia 30309 |
| Methodist Hospital | Houston, Texas 77030 |
| University of North Carolina | Chapel Hill, North Carolina 27599 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| Georgetown University | Washington, District of Columbia 20007-2197 |
| Cleveland Clinic | Cleveland, Ohio 44195 |
| University of Chicago Medical Center | Chicago, Illinois 60637 |
| Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
| UCLA | Los Angeles, California 90095 |
| University of Kentucky | Lexington, Kentucky 40536-0098 |
| New York University | New York, New York 10016 |
| Integris Baptist Medical Center | Oklahoma City, Oklahoma 73112 |
| Columbia University Medical Center | New York, New York 10032 |
| Memorial Hermann Hospital | Houston, Texas 77030 |
| University of Southern CA | Los Angeles, California 90033 |
| University of Colorado / Anchutz Cancer Pavilion | Aurora, Colorado 80045 |
| Lifelink, Inc | Tampa, Florida 33606 |
| Henry Ford Hospital Transplant Institute | Detroit, Michigan 48202 |
| Mayo Clinic Transplant Center | Rochester, Minnesota 55905 |
| UMD, Division of Transplant Surgery | Newark, New Jersey 07101 |
| Vanderbuilt Transplant Center | Nashville, Tennessee 37232 |
| The Baylor College of Medicine | Dallas, Texas 75203 |
| Methodist Dallas Liver Insititute | Dallas, Texas 75203 |
