Managed Access Programs for TQJ230, Pelacarsen

NCT ID: NCT07000695

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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The purpose of this registration is to list Managed Access Programs (MAPs) related to TQJ230, pelacarsen

Detailed Description

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CTQJ230A12013M - Available - Managed Access Program (MAP) Cohort Treatment Plan (CTQJ230A12013M) to provide access to pelacarsen (TQJ230) for (Atherosclerotic Cardiovascular Disease, ASCVD)

Conditions

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Atherosclerotic Cardiovascular Disease, ASCVD

Interventions

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Pelacarsen

Patients receive Pelacarsen

Intervention Type DRUG

Other Intervention Names

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TQJ230

Eligibility Criteria

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Inclusion Criteria

1. An independent request was received from a licensed physician.
2. 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.
3. The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
4. 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.
5. 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).
6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
7. Managed Access provision is allowed per local laws/regulations.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CTQJ230A12013M

Identifier Type: -

Identifier Source: org_study_id

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