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.
Interventions
Pelacarsen
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
Mainz,55131,Germany
Novartis Investigative Site
Recruiting
Muenchen,81377,Germany
Novartis Investigative Site
Recruiting
Ulm,89081,Germany
Novartis Investigative Site
Recruiting
Wuerzburg,97080,Germany
Novartis Investigative Site
Recruiting
Berlin,13353,Germany
Novartis Investigative Site
Recruiting
Dresden,01307,Germany
Worldwide Contacts
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