Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
study ends around

Description

Summary

This open-label extension study provides post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint.

Official Title

A Single Arm, Multicenter, Open-label Extension (OLE) Trial to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Participants Who Completed the Parent Lp(a)HORIZON Trial

Details

This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).

Keywords

Cardiovascular Disease and Lipoprotein(a), Lipoprotein(a),, Lp(a),, cardiovascular disease,, CVD,, myocardial infarction,, stroke,, OLE,, pelacarsen,, open-label, Cardiovascular Diseases, Myocardial Infarction, Stroke, pelacarsen, Pelacarsen (TQJ230)

Eligibility

You can join if…

Open to people ages 18-100

  • 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.

You CAN'T join if...

  • 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

  • University of Calif Irvine Med Cntr
    Irvine California 92660 United States
  • Diabetes Lipid Management Center
    Huntington Beach California 92648 United States
  • Memorial Care Health System
    Long Beach California 90806 United States
  • Valley Clinical Trials Inc
    Covina California 91723 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT07517263
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 5700 study participants
Last Updated