Status:
AVAILABLE
Managed Access Programs for LNP023, Iptacopan
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
C3 Glomerulopathy (C3G)
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this registration form is to list all Managed Access Programs (MAPs) related to LNP023, Iptacopan
Detailed 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 Kidn...
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.
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05222412
Last Update
December 5 2025
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