Last Update: Mar 26, 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:
NCT05900141
Novartis Reference Number:CTQJ230A12302E1
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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)
Phase 3
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

Study Location

Novartis Investigative Site

Recruiting

Muenchen,81377,Germany

Novartis Investigative Site

Recruiting

Wuerzburg,97080,Germany

Novartis Investigative Site

Recruiting

Berlin,13353,Germany

Novartis Investigative Site

Recruiting

Dresden,01307,Germany

Novartis Investigative Site

Recruiting

Mainz,55131,Germany

Worldwide Contacts

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Novartis Pharmaceuticals

+41613241111