Pelacarsen Roll-over Extension Program
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Pelacarsen (TQJ230)
Drugpelacarsen 80mg s.c. monthly
Treatment groups
599 Participants
are divided into 1 treatment groupGroup A: Pelacarsen (TQJ230)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse events (AEs) or serious adverse events (SAEs)
Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established atherosclerotic cardiovascular disease who have completed the parent study
Time frame
Up to 48 monthsSecondary outcomes
1
Observed value and change in Lipoprotein(a) (Lp(a)) compared to baseline of the parent study
Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels
Time frame
Baseline of the core study, Month 3, 12, 24, 36, 482
Observed value and change in Lp(a) compared to baseline of the rollover extension program (REP) study
Evaluate the long-term efficacy of pelacarsen (TQJ230) in lowering Lp(a) levels
Time frame
Baseline of the REP study, Month 3, 12, 24, 36, 48Sponsors and contacts
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Source ClinicalTrials.gov