Recruiting NCT07517263

An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

Phase III Interventional Cardiovascular Disease and Lipoprotein(a)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Pelacarsen (TQJ230).
Who it may be relevant to: Registry conditions: Cardiovascular Disease and Lipoprotein(a). Basic parameters: 18 years — 100 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +34
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Detailed description

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).

Interventions

Drug Pelacarsen (TQJ230)
pelacarsen 80mg s.c. monthly

Primary outcome measures

Number of participants with Adverse events [Time frame: Up to 36 months]

Secondary outcome measures (7)

Time to first occurrence of 4 Point-Major Cardiovascular Event (4P-MACE) from parent study baseline [Time frame: Up to 36 months]
Time to the first occurrence of 4P-MACE from open-label extension (OLE) study baseline [Time frame: Up to 36 months]
Cumulative number of 4P-MACE over time from OLE study baseline [Time frame: Up to 36 months]
Cumulative number of 4P-MACE over time from parent study baseline [Time frame: Up to 36 months]
Observed value of Lipoprotein(a) (Lp(a)) [Time frame: Baseline, Month 3, Month 12, Month 24, Month 36]
Change in Lp(a) compared to baseline of the OLE study [Time frame: Baseline, Month 3, Month 12, Month 24, Month 36]
Change in Lp(a) compared to baseline of the parent study [Time frame: Baseline, Month 3, Month 12, Month 24, Month 36]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment