An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
A Single Arm, Open Label Extension (OLE), Multicenter Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Patients With Cardiovascular Disease Who Have Successfully Completed the Apheresis Parent Study.
Sponsor: Novartis Pharmaceuticals
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Incidence of Adverse events (AEs) or serious adverse events (SAEs), including changes in laboratory evaluations, vital signs qualifying and reported as AEs.
Time frame: 60 months
Duration of drug exposure
Time frame: 60 months
Secondary Endpoints
Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5
Absolute change in Lp(a) compared to baseline of the parent study.
Percentage change in Lp(a) compared to baseline of the parent study.
Eligibility Criteria
Inclusion Criteria: * Signed informed consent * Participant has successfully completed the parent study and is considered safe to participate by Investigator's clinical judgement. Exclusion Criteria: * Any medical condition(s) that may put the participant at risk in the investigator's opinion * Pregnant or nursing (lactating) women * Women of child-bearing potential, unless they are using effective methods of contraception during dosing and for 16 weeks (= 5 times the terminal half-life) after stopping of study medication
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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