Managed Access Programs for LNP023, Iptacopan

Novartis Pharmaceuticals0 个研究点开始时间: 2022年2月3日最近更新: 2025年12月5日

适应症

试验速览

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

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).

•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.

发起方

申办方类型

Industry

责任方

Sponsor