NCT07517263 · Novartis Pharmaceuticals
An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
What this study is about
This where both patients and doctors know the treatment given extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the where neither patients nor doctors know which treatment is given parent study (CTQJ230A12301).
View original scientific description
This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
- Participants who have completed the parent study EOS visit while still on assigned investigational product.
Exclusion criteria
- Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
- Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.
- Participants are receiving another investigational drug or device before the open-label treatment period.
- Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit. Other protocol-defined inclusion/exclusion criteria may apply.
Where
- Andalusia, Alabama
- Huntsville, Alabama
- Mobile, Alabama
- Gilbert, Arizona
- Sun City West, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Beverly Hills, California
- Covina, California
- Huntington Beach, California
- Irvine, California
- Long Beach, California
And 92 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations