Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: April 23, 2010
Last updated: September 14, 2013
Last verified: September 2013

April 23, 2010
September 14, 2013
April 2010
April 2013   (final data collection date for primary 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 [ Time Frame: at 36 and 48 months post-transplantation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01150097 on ClinicalTrials.gov Archive Site
  • Incidence of hypertension, neurotoxicity, or new-onset diabetes mellitus (NODM) [ Time Frame: 36 and 48 months post-transplantation ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 36 and 48 months post-transplantation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
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).

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Transplant Recipient
  • Drug: Tacrolimus
  • Drug: Tacrolimus + everolimus
  • Drug: Everolimus
  • Active Comparator: Tacrolimus
    Intervention: Drug: Tacrolimus
  • Experimental: Low dose tacrolimus + everolimus
    Intervention: Drug: Tacrolimus + everolimus
  • Experimental: Everolimus
    Intervention: Drug: Everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Not Provided
April 2013   (final data collection date for primary outcome measure)

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

20 Years to 72 Years
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Colombia,   Czech Republic,   France,   Germany,   Hungary,   Ireland,   Italy,   Netherlands,   Russian Federation,   Spain,   Sweden,   United Kingdom
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP