Pelacarsen Roll-over Extension Program

NCT ID: NCT06875973

Last Updated: 2025-08-03

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

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-19

Study Completion Date

2028-01-03

Brief Summary

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This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).

Detailed Description

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This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.

Conditions

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Atherosclerotic Cardiovascular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Rollover extension program (REP)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label study

Study Groups

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Pelacarsen (TQJ230)

open-label pelacarsen 80mg

Group Type EXPERIMENTAL

Pelacarsen (TQJ230)

Intervention Type DRUG

pelacarsen 80mg s.c. monthly

Interventions

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Pelacarsen (TQJ230)

pelacarsen 80mg s.c. monthly

Intervention Type DRUG

Other Intervention Names

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TQJ230

Eligibility Criteria

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Inclusion Criteria

* Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
* Participants who have completed the parent study and received the assigned study treatment at the time of its completion

Exclusion Criteria

* Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study
* Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation
* Participants who are receiving another investigational drug or device before the open-label treatment period
* Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Parkway Medical Center

Birmingham, Alabama, United States

Site Status RECRUITING

National Heart Institute

Beverly Hills, California, United States

Site Status RECRUITING

Excel Medical Clinical Trials LLC

Boca Raton, Florida, United States

Site Status RECRUITING

Proactive Clinical Research

Fort Lauderdale, Florida, United States

Site Status RECRUITING

National Research Institute

Hialeah, Florida, United States

Site Status RECRUITING

Finlay Medical Research

Miami, Florida, United States

Site Status RECRUITING

Inpatient Research Clinical LLC

Miami Lakes, Florida, United States

Site Status RECRUITING

DBC Research USA

Pembroke Pines, Florida, United States

Site Status RECRUITING

Cardiology Partners Clinical Research Institute

Wellington, Florida, United States

Site Status RECRUITING

Cardiovascular Associates Research

Covington, Louisiana, United States

Site Status RECRUITING

Southern Clin Research Clinic

Zachary, Louisiana, United States

Site Status RECRUITING

Anderson Medical Research

Ft. Washington, Maryland, United States

Site Status RECRUITING

Capitol Cardiology Associates

Lanham, Maryland, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Aa Mrc Llc

Flint, Michigan, United States

Site Status RECRUITING

AB Clinical Trials

Las Vegas, Nevada, United States

Site Status RECRUITING

Clinical Research of South Nevada

Las Vegas, Nevada, United States

Site Status RECRUITING

Apex Cardiology Research Associates of Jackson

Jackson, Tennessee, United States

Site Status RECRUITING

North Hills Medical Research Inc

Bedford, Texas, United States

Site Status RECRUITING

Angiocardiac Care of Texas PA

Houston, Texas, United States

Site Status RECRUITING

Biopharma Informatic LLC

Houston, Texas, United States

Site Status RECRUITING

Biopharma Informatic LLC

Houston, Texas, United States

Site Status RECRUITING

Clinical Trials of Texas

San Antonio, Texas, United States

Site Status RECRUITING

Javara Research

Alexandria, Virginia, United States

Site Status RECRUITING

Virginia Heart

Falls Church, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

1-888-669-6682

Novartis Pharmaceuticals

Role: CONTACT

Facility Contacts

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Trina Gray

Role: primary

+1 205 815 5000

Maria Flores

Role: primary

+1 301 289 5221

Galaxy Gutierrez

Role: primary

+1 561 756 8206

Role: primary

+1 956 731 1260

Carolina Ramirez

Role: primary

Danay Yma

Role: primary

+1 305 459 3578

Jose Casola

Role: primary

+1 786 502 4303

Diana Zuniga

Role: primary

+1 954 537 2100

Hiromi Hauserman

Role: primary

+1 561 537 4778

Lori Barringer

Role: primary

Tammy Dours

Role: primary

Lian Glorioso

Role: primary

Marlin Dubon

Role: primary

+1 301 312 0575

Kayla A Woelmer

Role: primary

Rania Takriti

Role: primary

Role: primary

+1 702 804 5900

Rogers Estevez

Role: primary

+1 702 570 6107

Leslie Gibbons

Role: primary

+1 731 423 8200

Steven Vasquez

Role: primary

+1 817 595 3399

Siera Worthey

Role: primary

+1 877 339 0254

Alejandra Garcia

Role: primary

Derrell Sam

Role: primary

+1 281 944 3610

Adrienne Limon

Role: primary

+1 210 949 0122

Christina Good

Role: primary

+1 703 766 5920

Other Identifiers

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CTQJ230A12305B

Identifier Type: -

Identifier Source: org_study_id

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