This study is in progress, not accepting new patients

Pelacarsen Roll-over Extension Program

a study on Cardiovascular Disease Atherosclerosis Peripheral Artery Disease

Summary

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

Description

Summary

This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304). 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 Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open-Label Pelacarsen in Participants With Elevated Lp(a) and Established ASCVD

Details

This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.

Keywords

Atherosclerotic Cardiovascular Disease, TQJ230, Lp(a), ASCVD, Atherosclerosis, 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 and received the assigned study treatment at the time of its completion

You CAN'T join if...

  • 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.

Locations

  • University of Calif Irvine Med Cntr
    Irvine California 92660 United States
  • NICRs Research Center
    Garden Grove California 92844 United States
  • Long Beach Clinical Trials
    Long Beach California 90806 United States
  • Valley Clinical Trials Inc
    Covina California 91723 United States

Lead Scientist at UC Irvine

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT06875973
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 599 study participants
Last Updated