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

Novartis

Status

Conditions: Organ Transplantation

Treatments: Drug: everolimus (RAD)

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00149981

2004-001473-25

CRAD001A2401

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.