An open-label extension (OLE) trial to evaluate long-term safety and tolerability of pelacarsen (TQJ230)
EU CTIS ID: 2024-519870-38-00
What this study is testing
To evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established CVD who have completed the parent Lp(a)HORIZON study
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
- Pregnant or nursing (breastfeeding) women
- Women of childbearing potential unless they are using highly effective methods of contraception
The study team makes the final eligibility decision.
Where it's taking place
- Peru
- Guatemala
- Switzerland
- Israel
- Russian Federation
- United States
- Colombia
- China
- Argentina
- Korea, Democratic People's Republic of
- Turkey
- Japan
- Taiwan
- Mexico
- Hong Kong
- Canada
- India
- Brazil
- Chile
- United Kingdom
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peru; Guatemala; Switzerland; Israel; Russian Federation; United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.