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.

CTQJ230A12302E1

This non-randomized, open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants in Germany with hyperlipoproteinemia(a) and established cardiovascular disease who have successfully completed the double-blind parent study (CTQJ230A12302).

2023-09-29

2028-08-24

2028-08-24

Recruiting

Early phase I

60

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label extension (OLE) study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label study'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2024-03-26