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

Phase 3Active Not RecruitingNCT05900141

Novartis Pharmaceuticals41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperlipoproteinemia (a)

Interventions

PelacarsenDRUG

Pelacarsen 80mg s.c. monthly

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (9)

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Cloppenburg, Germany

Novartis Investigative Site

Dresden, Germany

Outcomes

Primary Outcomes

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

Time frame: 60 months

Duration of drug exposure

Duration of drug exposure will be collected

Time frame: 60 months

Secondary Outcomes

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.

Time frame: 60 months

Absolute change in Lp(a) compared to baseline of the parent study.

Evaluate the long-term effect of pelacarsen on Lp(a) change.

Time frame: 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.

Time frame: month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.