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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


Phase 3
20 Years
72 Years
Open (Enrolling)
Both
Liver Transplant Recipient

Thank you

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