Pelacarsen Roll-over Extension Program

Launched by NOVARTIS PHARMACEUTICALS · Mar 12, 2025

Keywords

ClinConnect Summary

The Pelacarsen Roll-over Extension Program is a clinical trial designed for people who have completed a previous study on a new treatment called pelacarsen (also known as TQJ230). This study aims to give these participants continued access to the treatment after they finish the initial trial. It's focused on individuals with a condition known as atherosclerotic cardiovascular disease, which affects the heart and blood vessels.

To be eligible for this trial, participants must have finished the earlier study and received the assigned treatment. They also need to have agreed to participate by giving informed consent. However, those who had to stop the treatment for any reason, such as side effects or other medical conditions, cannot join this new phase. During the trial, participants will be monitored closely to ensure their safety and to see how well the treatment works over a longer period. It's important to note that this trial is not yet recruiting participants, so there will be no immediate enrollment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
• • Participants who have completed the parent study and received the assigned study treatment at the time of its completion
• Exclusion Criteria:
• • Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study
• • Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation
• • Participants who are receiving another investigational drug or device before the open-label treatment period
• • Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator
• • Other protocol-defined inclusion/exclusion criteria may apply.