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
Novartis Pharmaceuticals
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).
Description
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.
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 investig…
Interventions
- DrugPelacarsen (TQJ230)
pelacarsen 80mg s.c. monthly
Locations (97)
- Parkway Medical CenterBirmingham, Alabama
- Cardiology and Medicine Clinic PALittle Rock, Arkansas
- National Heart InstituteBeverly Hills, California
- Hope Clinical ResearchCanoga Park, California
- Valley Clinical Trials IncCovina, California
- NICRs Research CenterGarden Grove, California