NCT05222412AvailableNot Applicable
Managed Access Programs for LNP023, Iptacopan
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Available
- Sponsor
- Novartis Pharmaceuticals
Study Overview
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 Kidneys.
- CLNP023N12001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLNP023N12001M to provide access to Iptacopan for patients with paroxysmal nocturnal hemoglobinuria (PNH).
Study Design
- Study Type
- Expanded Access
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 Criteria
- Not provided
Investigators
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