A facilitated access program to provide Everolimus (RAD) for maintenance for patients completing therapy in RAD trials in solid organ transplantation. - The umbrella protocol

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2004-001473-25-BE
• Date of registration: 09/12/2005
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals Corporation
• Public title: A facilitated access program to provide Everolimus (RAD) for maintenance for patients completing therapy in RAD trials in solid organ transplantation. - The umbrella protocol
• Scientific title: A facilitated access program to provide Everolimus (RAD) for maintenance for patients completing therapy in RAD trials in solid organ transplantation. - The umbrella protocol
• Date of first enrolment: 27/01/2005
• Target sample size: 1000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001473-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): Therapeutic confirmatory - (Phase III): Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject is currently enrolled in an everolimus (RAD) trial sponsored by Novartis.
2. Male or female 18 years of age or older.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Inability or unwillingness to comply with immunosuppressive regimen.
2. Pregnancy.
3. History of acute organ rejection within the last 3 months. These patients may be screened again when they have been without rejection for greater than 3 months.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Solid Organ Transplant - maintenace phase

Intervention(s)

Trade Name: Certican 0,5 mg tablet
Product Name: Everolimus
Product Code: RAD
Pharmaceutical Form: Tablet

Trade Name: Certican 0,75 mg tablet
Product Name: Everolimus
Product Code: RAD
Pharmaceutical Form: Tablet

Primary Outcome(s)

Primary end point(s): No efficacy assessments.

Secondary Objective:

Main Objective: 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 until drug is commercially available or the project has been discontinued.

Secondary ID(s)

CRAD001A2401