Last Update: May 31, 2024
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.
ClinicalTrials.gov Identifier:
Novartis Reference Number:CTQJ230A12302E1
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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). This study will allow to evaluate a long-term safety and tolerability of pelacarsen
(TQJ230) 80 mg QM in patients. All consenting participants from the parent study who meet
the eligibility criteria will be participating in this open label extension study. The
maximum duration of this study is approximately 5 years.

Hyperlipoproteinemia (a)
Phase3
Recruiting
60
Sep 29, 2023
Aug 24, 2028
All
18 Years - (Adult, Older Adult)

Interventions

Drug

Pelacarsen

Pelacarsen 80mg s.c. monthly

Eligibility Criteria

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

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