Managed Access Programs for LNP023, Iptacopan

Last updated: October 25, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Planned

Phase

N/A

Condition

Proteinuria

Hemoglobinuria, Paroxysmal

Anemia

Treatment

Iptacopan

Clinical Study ID

NCT05222412
CLNP023B12004M
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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.

Study Design

Treatment Group(s): 1
Primary Treatment: Iptacopan
Phase:
Study Start date:
Estimated Completion Date:

Study 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).