Clinical trial NCT05900141: An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
Official title: A Single Arm, Open Label Extension (OLE), Multicenter Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Patients With Cardiovascular Disease Who Have Successfully Completed the Apheresis Parent Study.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hyperlipoproteinemia (a)
Keywords: Lipoprotein(a)
Cardiovascular disease
Apheresis
Post trial access
pelacarsen (TQJ230)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label extension (OLE) study
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse events (AEs) or serious adverse events (SAEs), including changes in laboratory evaluations, vital signs qualifying and reported as AEs.
timeFrame: 60 months
measure: Duration of drug exposure
timeFrame: 60 months
Secondary outcomes:
measure: Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5
timeFrame: 60 months
measure: Absolute change in Lp(a) compared to baseline of the parent study.
timeFrame: month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)
measure: Percentage change in Lp(a) compared to baseline of the parent study.
timeFrame: month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Cloppenburg
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: