Managed Access Programs for LNP023, Iptacopan

Novartis

Status

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH); C3 Glomerulopathy (C3G)

Treatments: Drug: Iptacopan

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT05222412

CLNP023B12004M

Details and patient eligibility

About

The purpose of this registration form is to list all Managed Access Programs (MAPs) related to LNP023, Iptacopan

Full description

• CLNP023B12004M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023B12004M to Provide Access to Iptacopan (LNP023) for Complement 3 Glomerulopathy in Native and Transplanted Kidneys.
• CLNP023N12001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023N12001M to provide access to Iptacopan for patients with paroxysmal nocturnal hemoglobinuria (PNH).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• An independent request should be received from a licensed physician (in some instances from Health Authorities, Institutions or Governments).
• The patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options.
• The patient is not eligible or able to enroll in a Novartis clinical trial or continue participation in a Novartis clinical trial.
• 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.
• The patient must meet any other medical criteria established by the medical experts responsible for the product or by the Health Authority in a country (as applicable).
• Provision of the product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program.
• Managed access provision is allowed per local laws/regulations.