Clinical trial NCT01150097: Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Transplant Recipient
Keywords: Liver transplantation
Everolimus
Calcineurin inhibitors
Tacrolimus
Renal function
Progression of HCV related allograft fibrosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-06-24
Enrollment: 284
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death
timeFrame: from months 24 to 36
measure: Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death
timeFrame: from months 36 to 48
measure: Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death
timeFrame: from months 24 to 36
measure: Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death
timeFrame: from months 36 - 48
measure: Change in Renal Function
timeFrame: from months 24 to 36
Secondary outcomes:
measure: Incidence Rate of tBPAR
timeFrame: from months 24 - 36
Other outcomes:
Locations:
city: Washington
country: United States
facility: Novartis Investigative Site
state: District of Columbia
city: Tampa
country: United States
facility: Novartis Investigative Site
state: Florida
city: Lexington
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Detroit
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Rochester
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Newark
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Chapel Hill
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Durham
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: San Martin
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Camperdown
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Bedford Park
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Heidelberg
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Cali
country: Colombia
facility: Novartis Investigative Site
state: Valle Del Cauca
city: Bogota
country: Colombia
facility: Novartis Investigative Site
city: Praha 4
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Clichy
country: France
facility: Novartis Investigative Site
city: Creteil
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Villejuif
country: France
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Dublin 4
country: Ireland
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Modena
country: Italy
facility: Novartis Investigative Site
state: MO
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Baracaldo
country: Spain
facility: Novartis Investigative Site
state: Vizcaya
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Edinburgh
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: