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

This study is currently recruiting participants.
Verified April 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01150097
First received: April 23, 2010
Last updated: April 28, 2012
Last verified: April 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Liver Transplant Recipient
 Drug: Tacrolimus
Drug: Tacrolimus + everolimus
Drug: Everolimus
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 470
Study Start Date: April 2010
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tacrolimus Drug: Tacrolimus
Experimental: Low dose tacrolimus + everolimus Drug: Tacrolimus + everolimus
Experimental: Everolimus Drug: Everolimus

  Eligibility

Ages Eligible for Study:   20 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150097

Contacts
Contact: Novartis Pharmaceuticals 862-778-8300

  Show 88 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01150097     History of Changes
Other Study ID Numbers: CRAD001H2304E1
Study First Received: April 23, 2010
Last Updated: April 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Liver transplantation
Everolimus
Calcineurin inhibitors
 Tacrolimus
Renal function
Progression of HCV related allograft fibrosis

Additional relevant MeSH terms:
Everolimus
Sirolimus
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 22, 2013