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

Study acronym: OLE
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Eligibility criteria expanded, about 5 words
  2. Re-verified, no change to tracked fieldsv12
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 60 to confirmed 41
    • Study sites: 7 to 9
    v11
  4. Re-verified, no change to tracked fieldsv10
  5. Study sites: 6 to 7v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 5 to 6v8
  2. Study sites: 4 to 5v7
  3. Study sites: 2 to 4v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 28, 2023 to Sep 29, 2023
    v5
  5. Primary completion date: Aug 11, 2028 to Aug 24, 2028v4
  6. Study completion date: Aug 11, 2028 to Aug 24, 2028v3
  7. Start date: Aug 15, 2023 to Sep 28, 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novartis
555 trials monitored
See 34 trials at risk
This non-randomized, open-label extension study provides 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). Study has been terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint
Trial Details
NCT Number NCT05900141
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Hyperlipoproteinemia (a)
Related terms Cardiovascular Diseases, Hyperlipoproteinemias
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov