En Open Label Extension (OLE) undersøgelse for at evaluere langsigtet sikkerhed og tolerabilitet af Pelacarsen (TQJ230) (OLE)
En enkeltarm, åben etiketforlængelse (OLE), multicenterundersøgelse til evaluering af langsigtet sikkerhed og tolerabilitet af Pelacarsen (TQJ230) hos patienter med hjerte-kar-sygdomme, som har gennemført afereseforælderundersøgelsen.
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Berlin, Tyskland, 13353
- Novartis Investigative Site
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Cloppenburg, Tyskland, 49661
- Novartis Investigative Site
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Erlangen, Tyskland, 91054
- Novartis Investigative Site
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Mainz, Tyskland, 55131
- Novartis Investigative Site
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Ulm, Tyskland, 89081
- Novartis Investigative Site
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Bavaria
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Munich, Bavaria, Tyskland, 81377
- Novartis Investigative Site
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Würzburg, Bavaria, Tyskland, 97080
- Novartis Investigative Site
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Hesse
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Frankfurt am Main, Hesse, Tyskland, 60431
- Novartis Investigative Site
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Saxony
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Dresden, Saxony, Tyskland, 01307
- Novartis Investigative Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Pelacarsen (TQJ230)
open-label pelacarsen 80 mg |
Pelacarsen 80mg s.c. monthly
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Adverse events (AEs) or serious adverse events (SAEs), including changes in laboratory evaluations, vital signs qualifying and reported as AEs.
Tidsramme: 60 months
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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
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Duration of drug exposure
Tidsramme: 60 months
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Duration of drug exposure will be collected |
60 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5
Tidsramme: 60 months
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Evaluate the long-term effect of pelacarsen on the need for lipoprotein apheresis. |
60 months
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Absolute change in Lp(a) compared to baseline of the parent study.
Tidsramme: month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)
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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)
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Percentage change in Lp(a) compared to baseline of the parent study.
Tidsramme: month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)
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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)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CTQJ230A12302E1
- 2023-503611-16-00 (Registry Identifier: EUCTR)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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