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

Novartis

Status and phase: Active, not recruiting; Phase 3

Conditions: Hyperlipoproteinemia (a)

Treatments: Drug: Pelacarsen

Study type: Interventional

Funder types: Industry

Identifiers

NCT05900141

2023-503611-16-00 (Registry Identifier)

CTQJ230A12302E1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Pelacarsen (TQJ230)

Experimental group

Description:

open-label pelacarsen 80 mg

Treatment:

Drug: Pelacarsen