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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 6, 2005

Last Updated Date

September 17, 2008

Start Date ^†

January 2004

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

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

Change History

Complete list of historical versions of study NCT00149981 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study

Condition ^†

Solid Organ Transplantation

Intervention ^†

Drug: Everolimus (RAD)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00149981

Responsible Party

Novartis, Novartis

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

September 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.