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 Frontiers Apheresis parent study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503611-16-00

Acronym

CTQJ230A12302E1

Enrollment

Registered

2023-09-13

Start date

2023-09-29

Completion date

Unknown

Last updated

2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apheresis

Brief summary

Adverse events (AEs) or serious adverse events (SAEs), laboratory evaluations, vital signs and duration of drug exposure

Detailed description

Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5, Absolute and percentage change in Lp(a) on month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE compared to baseline of the parent study

Interventions

DRUGTQJ230

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Adverse events (AEs) or serious adverse events (SAEs), laboratory evaluations, vital signs and duration of drug exposure	—

Secondary

Measure	Time frame
Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5, Absolute and percentage change in Lp(a) on month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE compared to baseline of the parent study	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026