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Clinical Trial ยท PHASE3 ยท Recruiting

An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

07 September 2026 NCT07517263 ClinicalTrials.gov โ†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE3
Participants
ALL
Age Range
18 Years โ€“ 100 Years

About This Trial

This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).

Who Can Join?

Inclusion Criteria: * Participants who have provided informed consent prior to initiation of any study-specific activities/procedures. * Participants who have completed the parent study EOS visit while still on assigned investigational product. Exclusion Criteria: * Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study. * Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5. * Participants are receiving another investigational drug or device before the open-label treatment period. * Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit. Other…

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