RECRUITING

Pelacarsen Roll-over Extension Program

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Conditions

Atherosclerotic Cardiovascular DiseaseTQJ230Lp(a)ASCVD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open-Label Pelacarsen in Participants With Elevated Lp(a) and Established ASCVD

Quick Facts

Study Start:2025-05-19
Study Completion:2028-01-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06875973

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
  2. * Participants who have completed the parent study and received the assigned study treatment at the time of its completion
  1. * Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study
  2. * Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation
  3. * Participants who are receiving another investigational drug or device before the open-label treatment period
  4. * Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT

Study Locations (Sites)

Parkway Medical Center
Birmingham, Alabama, 35215
United States
National Heart Institute
Beverly Hills, California, 90211
United States
Excel Medical Clinical Trials LLC
Boca Raton, Florida, 33434
United States
Proactive Clinical Research
Fort Lauderdale, Florida, 33308
United States
National Research Institute
Hialeah, Florida, 33013
United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014
United States
Finlay Medical Research
Miami, Florida, 33126
United States
DBC Research USA
Pembroke Pines, Florida, 33029
United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449
United States
Cardiovascular Associates Research
Covington, Louisiana, 70433
United States
Southern Clin Research Clinic
Zachary, Louisiana, 70791
United States
Anderson Medical Research
Fort Washington, Maryland, 20744
United States
Capitol Cardiology Associates
Lanham, Maryland, 20706
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Aa Mrc Llc
Flint, Michigan, 48504
United States
AB Clinical Trials
Las Vegas, Nevada, 89119
United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121
United States
Apex Cardiology Research Associates of Jackson
Jackson, Tennessee, 38301
United States
North Hills Medical Research Inc
Bedford, Texas, 76021
United States
Angiocardiac Care of Texas PA
Houston, Texas, 77025
United States
Biopharma Informatic LLC
Houston, Texas, 77084
United States
Biopharma Informatic LLC
Houston, Texas, 77084
United States
Clinical Trials of Texas
San Antonio, Texas, 78229
United States
Javara Research
Alexandria, Virginia, 22311
United States
Virginia Heart
Falls Church, Virginia, 22042
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-19
Study Completion Date2028-01-03

Study Record Updates

Study Start Date2025-05-19
Study Completion Date2028-01-03

Terms related to this study

Keywords Provided by Researchers

  • TQJ230
  • Lp(a)
  • ASCVD

Additional Relevant MeSH Terms

  • Atherosclerotic Cardiovascular Disease