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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Transplant Recipient

Intervention: Tacrolimus (reduced tacrolimus) (Drug); Everolimus (reduced tacrolimus) (Drug); Tacrolimus (tacrolimus elimination) (Drug); Everolimus (tacrolimus elimination) (Drug); Tacrolimus (tacrolimus control) (Drug); Corticosteroids (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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).

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death

Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death

Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death

Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death

Change in Renal Function

Secondary outcome: Incidence Rate of tBPAR

Eligibility

Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Novartis Investigative Site, Gent 9000, Belgium

Novartis Investigative Site, Leuven 3000, Belgium

Novartis Investigative Site, Liege 4000, Belgium

Novartis Investigative Site, Bogotá, Colombia

Novartis Investigative Site, Cali, Colombia

Novartis Investigative Site, Praha 4 140 21, Czech Republic

Novartis Investigative Site, Bordeaux Cedex 33076, France

Novartis Investigative Site, Clichy 92110, France

Novartis Investigative Site, Creteil 94010, France

Novartis Investigative Site, Marseille 13385, France

Novartis Investigative Site, Montpellier 34295, France

Novartis Investigative Site, Villejuif 94805, France

Novartis Investigative Site, Berlin 13353, Germany

Novartis Investigative Site, Essen 45147, Germany

Novartis Investigative Site, Hamburg 20246, Germany

Novartis Investigative Site, Heidelberg 69120, Germany

Novartis Investigative Site, Leipzig 04103, Germany

Novartis Investigative Site, Mainz 55131, Germany

Novartis Investigative Site, Regensburg 93053, Germany

Novartis Investigative Site, Dublin 4, Ireland

Novartis Investigative Site, Rotterdam 3015 CE, Netherlands

Novartis Investigative Site, Moscow 123182, Russian Federation

Novartis Investigative Site, Moscow 129010, Russian Federation

Novartis Investigative Site, Stockholm 141 86, Sweden

Novartis Investigative Site, Edinburgh EH16 4SA, United Kingdom

Novartis Investigative Site, Hospitalet de Llobregat, Barcelona 08907, Spain

Novartis Investigative Site, Caba, Buenos Aires C1118AAT, Argentina

Novartis Investigative Site, San Martin, Buenos Aires C1107BEA, Argentina

Novartis Investigative Site, Barcelona, Catalunya 08035, Spain

Novartis Investigative Site, Barcelona, Catalunya 08036, Spain

Novartis Investigative Site, Valencia, Comunidad Valenciana 46026, Spain

Novartis Investigative Site, Washington, District of Columbia 20007-2197, United States

Novartis Investigative Site, Tampa, Florida 33606, United States

Novartis Investigative Site, Lexington, Kentucky 40536-0293, United States

Novartis Investigative Site, Milano, MI 20162, Italy

Novartis Investigative Site, Modena, MO 41100, Italy

Novartis Investigative Site, Detroit, Michigan 48202-2689, United States

Novartis Investigative Site, Rochester, Minnesota 55905, United States

Novartis Investigative Site, St. Louis, Missouri 63110, United States

Novartis Investigative Site, Newark, New Jersey 07101, United States

Novartis Investigative Site, Camperdown, New South Wales 2050, Australia

Novartis Investigative Site, New York, New York 10016, United States

Novartis Investigative Site, New York, New York 10032, United States

Novartis Investigative Site, Chapel Hill, North Carolina 27599, United States

Novartis Investigative Site, Durham, North Carolina 27710, United States

Novartis Investigative Site, Oklahoma City, Oklahoma 73112, United States

Novartis Investigative Site, Pisa, PI 56124, Italy

Novartis Investigative Site, Baracaldo, Pais Vasco 48903, Spain

Novartis Investigative Site, Rio de Janeiro, RJ 21041-030, Brazil

Novartis Investigative Site, Roma, RM 00161, Italy

Novartis Investigative Site, Porto Alegre, RS 90020-090, Brazil

Novartis Investigative Site, Bedford Park, South Australia 5042, Australia

Novartis Investigative Site, Charleston, South Carolina 29425, United States

Novartis Investigative Site, Torino, TO 10126, Italy

Novartis Investigative Site, Houston, Texas 77030-2400, United States

Novartis Investigative Site, Houston, Texas 77030, United States

Novartis Investigative Site, Heidelberg, Victoria 3084, Australia

Additional Information

Starting date: March 2010
Last updated: March 12, 2015

Page last updated: August 23, 2015

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