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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-29

Study Completion Date

2028-08-24

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Hyperlipoproteinemia (a)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label extension (OLE) study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label study

Study Groups

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Pelacarsen (TQJ230)

open-label pelacarsen 80 mg

Group Type EXPERIMENTAL

Pelacarsen

Intervention Type DRUG

Pelacarsen 80mg s.c. monthly

Interventions

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Pelacarsen

Pelacarsen 80mg s.c. monthly

Intervention Type DRUG

Other Intervention Names

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TQJ230

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No