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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503611-16-00 | Registry Identifier | EUCTR |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelacarsen (TQJ230) | Experimental | open-label pelacarsen 80 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelacarsen | Drug | Pelacarsen 80mg s.c. monthly |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events (AEs) or serious adverse events (SAEs), including changes in laboratory evaluations, vital signs qualifying and reported as AEs. | Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established cardiovascular disease who have competed the parent study | 60 months |
| Duration of drug exposure | Duration of drug exposure will be collected | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5 | Evaluate the long-term effect of pelacarsen on the need for lipoprotein apheresis. | 60 months |
| Absolute change in Lp(a) compared to baseline of the parent study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Frankfurt am Main | Hesse | 60431 | Germany | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| ID | Term |
|---|---|
| D006951 | Hyperlipoproteinemias |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000730804 | pelacarsen |
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Open-label extension (OLE) study
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Open label study
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Evaluate the long-term effect of pelacarsen on Lp(a) change.
| month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months) |
| Percentage change in Lp(a) compared to baseline of the parent study. | Evaluate the long-term effect of pelacarsen on Lp(a) change. | month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months) |
| Berlin |
| 13353 |
| Germany |
| Novartis Investigative Site | Cloppenburg | 49661 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | München | 81377 | Germany |
| Novartis Investigative Site | Ulm | 89081 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| D009750 |
| Nutritional and Metabolic Diseases |