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A randomized, double-blind, placebo-controlled, multicenter trial assessing the reduction of the rate of lipoprotein apheresis after treatment with pelacarsen (TQJ230) compared to placebo in patients with hyperlipoproteinemia(a) and established cardiovascular disease undergoing weekly lipoprotein apheresis in Germany

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508324-35-00
Acronym
CTQJ230A12302
Enrollment
51
Registered
2024-04-24
Start date
2022-08-19
Completion date
2025-01-28
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apheresis

Brief summary

Rate of lipoprotein apheresis sessions performed over 52 weeks normalized to the weekly lipoprotein apheresis schedule

Detailed description

Time to lipoprotein apheresis avoidance (where lipoprotein apheresis avoidance is defined as at least 24 weeks of no lipoprotein apheresis until end of study), Total avoidance of lipoprotein apheresis from week 12 to week 52, Change from baseline to week 52 in the log-transformed Lp(a) (measured prior to planned lipoprotein apheresis)

Interventions

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Rate of lipoprotein apheresis sessions performed over 52 weeks normalized to the weekly lipoprotein apheresis schedule

Secondary

MeasureTime frame
Time to lipoprotein apheresis avoidance (where lipoprotein apheresis avoidance is defined as at least 24 weeks of no lipoprotein apheresis until end of study), Total avoidance of lipoprotein apheresis from week 12 to week 52, Change from baseline to week 52 in the log-transformed Lp(a) (measured prior to planned lipoprotein apheresis)

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026