Managed Access Programs for VAY736, Ianalumab

Novartis

Status

Conditions: Primary Immune Thrombocytopenia; Sjögren's Syndrome

Treatments: Drug: ianalumab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT07244289

CVAY736I12003M

Details and patient eligibility

About

The purpose of this registration is to list Managed Access Programs (MAPs) related to VAY736, ianalumab

Full description

• CVAY736I12003M - Available - Managed Access Program (MAP) Cohort Treatment Plan CVAY736I12003M to provide access to ianalumab (VAY736) for patients with Primary Immune Thrombocytopenia (ITP)
• CVAY736A1002M - Not yet available - Managed Access Program (MAP) Cohort Treatment Plan CVAY736A1002M to provide access to ianalumab for adult patients with Sjögren's disease

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. An independent request was received from a licensed physician.
2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
3. The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
7. Managed Access provision is allowed per local laws/regulations.