An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)

Last updated: April 14, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Pelacarsen

Clinical Study ID

NCT05900141
CTQJ230A12302E1
2023-503611-16-00
  • Ages 18-100
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent

  • Participant has successfully completed the parent study and is considered safe toparticipate by Investigator's clinical judgement.

Exclusion

Exclusion Criteria:

  • Any medical condition(s) that may put the participant at risk in the investigator'sopinion

  • Pregnant or nursing (lactating) women

  • Women of child-bearing potential, unless they are using effective methods ofcontraception during dosing and for 16 weeks (= 5 times the terminal half-life)after stopping of study medication

Study Design

Total Participants: 41
Treatment Group(s): 1
Primary Treatment: Pelacarsen
Phase: 3
Study Start date:
September 29, 2023
Estimated Completion Date:
August 24, 2028

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Frankfurt am Main, Hessen 60431
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Site Not Available

  • Novartis Investigative Site

    Cloppenburg, 49661
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erlangen, 91054
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt, 60431
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mainz, 55131
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen, 81377
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ulm, 89081
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wuerzburg, 97080
    Germany

    Site Not Available

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