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

NCT07517263

RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Cardiovascular Disease and Lipoprotein(a)

Interventions: Pelacarsen (TQJ230)

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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 protocol-defined inclusion/exclusion criteria may apply.
Locations (643)
  • Andalusia, Alabama, United States
  • Huntsville, Alabama, United States
  • Mobile, Alabama, United States
  • Gilbert, Arizona, United States
  • Sun City West, Arizona, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Beverly Hills, California, United States
  • Beverly Hills, California, United States
  • Covina, California, United States
  • Huntington Beach, California, United States
  • Irvine, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Northridge, California, United States
  • Palo Alto, California, United States
  • San Diego, California, United States
  • San Francisco, California, United States
  • Santa Ana, California, United States
  • Stockton, California, United States
  • West Hills, California, United States
  • Aurora, Colorado, United States
  • Bridgeport, Connecticut, United States
  • Hartford, Connecticut, United States
  • Waterbury, Connecticut, United States
  • Boca Raton, Florida, United States
  • Brandon, Florida, United States
  • Jacksonville, Florida, United States
  • Naples, Florida, United States
  • Port Charlotte, Florida, United States
  • + 613 more on CT.gov