Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Eveline O Stock (ucsf)
Headshot of Eveline O Stock
Eveline O Stock

Description

Summary

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).

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

  • UCSF accepting new patients
    San Francisco California 94115 United States
  • Helping Hands Medical Associates INC accepting new patients
    Santa Ana California 92704 United States
  • Interv Cardiology Med Grp accepting new patients
    West Hills California 91307 United States

Lead Scientist at University of California Health

  • Eveline O Stock (ucsf)
    Dr. Eveline Oestreicher Stock is a cardiologist specializing in general cardiology and cholesterol metabolism disorders. Her special interests include preventive cardiology, mechanisms of coronary artery disease, heart disease risk assessment, and heart disease women and in the young.

Details

Status
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