Status:
AVAILABLE
Managed Access Programs for TQJ230, Pelacarsen
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Atherosclerotic Cardiovascular Disease, ASCVD
Eligibility:
All Genders
18-80 years
Brief Summary
The purpose of this registration is to list Managed Access Programs (MAPs) related to TQJ230, pelacarsen
Detailed Description
CTQJ230A12013M - Available - Managed Access Program (MAP) Cohort Treatment Plan (CTQJ230A12013M) to provide access to pelacarsen (TQJ230) for (Atherosclerotic Cardiovascular Disease, ASCVD)
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- An independent request was received from a licensed physician.
- The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
- The patient is not eligible or able to enrol in a clinical trial or continue participation in such 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 the country of request (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
NCT07000695
Last Update
June 3 2025
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