HORIZON OLE
Brief description of study
This is an open-label, single arm, multicenter extension study for participants with established CVD and elevated Lp(a) who completed the parent study. The purpose of this study is to assess the long-term safety and tolerability of pelacarsen (TQJ230). The study consists of: Screening period (up to approximately 30 days) and Open-label treatment period (minimum 24 months).
Detailed description of study
Enrolled participants will be provided with continued access to pelacarsen (TQJ230) for a minimum duration of 24 months and until (whichever is sooner):
• 3 years after LPFV of the participant in the country, or
• the benefit-risk profile of pelacarsen (TQJ230) is no longer positive, or
• pelacarsen (TQJ230) becomes commercially available and subsequently reimbursed in the country or, when reimbursement is not possible, the product is launched in the country, or,
• if a marketing application of an investigator product is rejected in a region/country for the indication under study.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: 99 years or below
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Gender: All
Inclusion
- 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
- Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
- Receiving another investigational drug or device before the open-label treatment period
- Have a known sensitivity to the study drug
- People who are pregnant or breastfeeding
- People of childbearing potential unless they are using highly effective contraception methods
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