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NCT00149981 Clinical Trial

A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

Organ Transplantation Clinical Trial

Official title:
A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00149981
Other study ID # CRAD001A2401
Secondary ID 2004-001473-25
Status No longer available
Phase
First received
Last updated

Study information
Verified date September 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties

Description:

This is a treatment protocol designed only to provide access to everolimus (RAD) for maintenance immunosuppression. The objectives are to facilitate the management of patients on maintenance immunosuppression therapy who are completing everolimus trials,

- To provide everolimus maintenance therapy through this access program and

- To collect and review safety data for up to 120 months or until the project has been discontinued whichever comes first.

- To collect and review safety data for up to 120 months or when Certican is commercially available in the given indication and reimbursed by appropriate payors or the project has been discontinued whichever comes first.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male or female recipients of solid organ transplants

- Subject is currently enrolled in an everolimus (RAD) trial sponsored by Novartis

- Currently on investigational drug everolimus (RAD) therapy

Exclusion Criteria:

- Inability or unwillingness to comply with immunosuppressive regimen.

- Pregnancy.

- History of acute organ rejection within the last 3 months.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• everolimus (RAD)
Everolimus

Locations
Country Name City State
Australia Novartis Investigative Site Camperdown New South Wales
Australia Novartis Investigative Site Clayton Victoria
Australia Novartis Investigative Site Darlinghurst New South Wales
Australia Novartis Investigative Site Parkville Victoria
Australia Novartis Investigative Site Woolloongabba Queensland
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Leuven
Brazil Novartis Investigative Site Belo Horizonte MG
Brazil Novartis Investigative Site Porto Alegre RS
Brazil Novartis Investigative Site Sao Paulo SP
Brazil Novartis Investigative Site São Paulo SP
Canada Novartis Investigative Site Edmonton Alberta
Canada Novartis Investigative Site Halifax Nova Scotia
Canada Novartis Investigative Site Hamilton Ontario
Canada Novartis Investigative Site London Ontario
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Sainte Foy Quebec
Canada Novartis Investigative Site Saskatoon Saskatchewan
Canada Novartis Investigative Site Toronto Ontario
Canada Novartis Investigative Site Toronto Ontario
Canada Novartis Investigative Site Vancouver British Columbia
Czechia Novartis Investigative Site Brno
Czechia Novartis Investigative Site Hradec Kralove
Czechia Novartis Investigative Site Ostrava-Poruba
Czechia Novartis Investigative Site Prague 4
France Novartis Investigative Site Brest
France Novartis Investigative Site Créteil
France Novartis Investigative Site Grenoble CEDEX
France Novartis Investigative Site Le Plessis Robinson
France Novartis Investigative Site Lyon
France Novartis Investigative Site Monpellier
France Novartis Investigative Site Nantes
France Novartis Investigative Site Paris
France Novartis Investigative Site Paris
France Novartis Investigative Site Saint-Etienne
France Novartis Investigative Site Toulouse
France Novartis Investigative Site Tours
France Novartis Investigative Site Vandoeuvre-Les-Nancy
France Novartis Investigative Site Villejuif
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Heidelberg
Germany Novartis Investigative Site Kiel
Germany Novartis Investigative Site Regensburg Bavaria
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Milano MI
Italy Novartis Investigative Site Padova PD
Italy Novartis Investigative Site Parma PR
Italy Novartis Investigative Site Pavia PV
Italy Novartis Investigative Site Perugia PG
Italy Novartis Investigative Site Pisa PI
Italy Novartis Investigative Site Roma RM
Italy Novartis Investigative Site Sassari SS
Italy Novartis Investigative Site Siena SI
Italy Novartis Investigative Site Vicenza VI
New Zealand Novartis Investigative Site Auckland
Norway Novartis Investigative Site Oslo
Poland Novartis Investigative Site Warszawa
Puerto Rico Novartis Investigative Site San Juan
Russian Federation Novartis Investigative Site Moscow
South Africa Novartis Investigative Site Johannesburg
Spain Novartis Investigative Site Baracaldo Vizcaya
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Cordoba Andalucia
Spain Novartis Investigative Site Hospitalet de Llobregat Barcelona
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Santander Cantabria
Spain Novartis Investigative Site Valencia Comunidad Valenciana
Switzerland Novartis Investigative Site Bern
Switzerland Novartis Investigative Site Zuerich
Taiwan Novartis Investigative Site Taichung Taiwan ROC
Taiwan Novartis Investigative Site Taichung
Taiwan Novartis Investigative Site Tainan Taiwan ROC
Taiwan Novartis Investigative Site Taipei
Taiwan Novartis Investigative Site Taoyuan
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site Manchester
United Kingdom Novartis Investigative Site Salford
United States Novartis Investigative Site Albany New York
United States Novartis Investigative Site Ann Arbor Michigan
United States Novartis Investigative Site Atlanta Georgia
United States Novartis Investigative Site Atlanta Georgia
United States Novartis Investigative Site Augusta Georgia
United States Novartis Investigative Site Aurora Colorado
United States Novartis Investigative Site Baltimore Maryland
United States Novartis Investigative Site Birmingham Alabama
United States Novartis Investigative Site Birmingham Alabama
United States Novartis Investigative Site Boston Massachusetts
United States Novartis Investigative Site Bronx New York
United States Novartis Investigative Site Buffalo New York
United States Novartis Investigative Site Charleston South Carolina
United States Novartis Investigative Site Charleston South Carolina
United States Novartis Investigative Site Charleston West Virginia
United States Novartis Investigative Site Charlottesville Virginia
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Cleveland Ohio
United States Novartis Investigative Site Cleveland Ohio
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Columbus Ohio
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Denver Colorado
United States Novartis Investigative Site Des Moines Iowa
United States Novartis Investigative Site Durham North Carolina
United States Novartis Investigative Site Fargo North Dakota
United States Novartis Investigative Site Gainesville Florida
United States Novartis Investigative Site Galveston Texas
United States Novartis Investigative Site Greenville North Carolina
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Lexington Kentucky
United States Novartis Investigative Site Livingston New Jersey
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Madison Wisconsin
United States Novartis Investigative Site Maywood Illinois
United States Novartis Investigative Site Milwaukee Wisconsin
United States Novartis Investigative Site Mobile Alabama
United States Novartis Investigative Site Murray Utah
United States Novartis Investigative Site Nashville Tennessee
United States Novartis Investigative Site New Brunswick New Jersey
United States Novartis Investigative Site New Haven Connecticut
United States Novartis Investigative Site New Orleans Louisiana
United States Novartis Investigative Site New Orleans Louisiana
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site Norfolk Virginia
United States Novartis Investigative Site Omaha Nebraska
United States Novartis Investigative Site Philadelphia Pennsylvania
United States Novartis Investigative Site Philadelphia Pennsylvania
United States Novartis Investigative Site Philadelphia Pennsylvania
United States Novartis Investigative Site Providence Rhode Island
United States Novartis Investigative Site Richmond Virginia
United States Novartis Investigative Site Saint Louis Missouri
United States Novartis Investigative Site Saint Louis Missouri
United States Novartis Investigative Site Salt Lake City Utah
United States Novartis Investigative Site San Antonio Texas
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site San Francisco California
United States Novartis Investigative Site Shreveport Louisiana
United States Novartis Investigative Site Stanford California
United States Novartis Investigative Site Tampa Florida
United States Novartis Investigative Site Valhalla New York
United States Novartis Investigative Site Winston-Salem North Carolina
United States Novartis Investigative Site Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Czechia,  France,  Germany,  Italy,  New Zealand,  Norway,  Poland,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

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