In short
Currently, there are 2 ongoing clinical trials exploring new treatment approaches for patients undergoing apheresis procedures. These studies are investigating pelacarsen, a medication that may reduce the need for regular apheresis sessions in patients with high lipoprotein(a) levels and cardiovascular disease. Both trials are being conducted in Germany and aim to improve treatment options and quality of life for affected patients.
Clinical trial locations
- Germany
Study on Long-Term Safety of Pelacarsen for Patients with Cardiovascular Disease Who Completed the Frontiers Apheresis Study
This trial focuses on evaluating the long-term safety of pelacarsen (also known as TQJ230) in patients with cardiovascular disease who have already completed a previous related study. The medication is administered as an injection under the skin using a pre-filled syringe.
Main inclusion criteria:
- Patients must have successfully completed a previous study called the "parent study" and be considered safe to continue treatment by their doctor
- Participants must provide signed informed consent, confirming they understand and agree to participate
- Both men and women from adult and older adult age groups can participate
Main exclusion criteria:
- Patients who are currently undergoing apheresis procedures cannot participate. Apheresis is a medical procedure where blood is taken from the body, a part of it is removed or treated, and then the rest is returned to the body
Study focus: The trial aims to monitor the long-term safety and tolerability of pelacarsen over an extended period, potentially up to five years until September 2028. Researchers will track any adverse effects, changes in laboratory results and vital signs, and measure the number of lipoprotein apheresis sessions performed yearly. The study will also measure changes in lipoprotein(a) levels at regular intervals to understand the long-term impact on cardiovascular health.
Investigational drug: Pelacarsen (TQJ230) is an antisense oligonucleotide that works by targeting and reducing the production of lipoprotein(a) in the liver. Lipoprotein(a) is a type of fat in the blood that can increase the risk of heart disease.
Study on Reducing Lipoprotein Apheresis with Pelacarsen in Patients with High Lipoprotein(a) and Heart Disease in Germany
This trial investigates whether pelacarsen can reduce the need for regular lipoprotein apheresis sessions in patients with high lipoprotein(a) levels and established cardiovascular disease. The study is designed as a double-blind trial, meaning neither participants nor researchers know who receives the active medication versus a placebo.
Main inclusion criteria:
- Patients must be currently undergoing weekly lipoprotein apheresis in Germany for at least 12 months, with at least 35 sessions in the past year
- Lipoprotein(a) levels must be greater than 60 mg/dL at screening
- Patients must have had a previous heart attack at least 3 months before screening, or have experienced an ischemic stroke, or have significant symptomatic peripheral or coronary artery disease
- Both men and women are eligible to participate
Main exclusion criteria:
- Patients who do not have hyperlipoproteinemia(a), which is characterized by high levels of a specific type of fat in the blood
- Patients who do not have established cardiovascular disease
- Patients not within the specified age range or unable to follow study procedures
Study focus: The primary goal is to determine whether pelacarsen can decrease the rate of lipoprotein apheresis sessions over a 52-week treatment period. The study will compare the effects of pelacarsen with those of a placebo, monitoring the frequency of apheresis sessions, changes in lipoprotein(a) levels, and the time to avoidance of apheresis sessions. The trial is expected to conclude by January 2025.
Investigational drug: Pelacarsen (TQJ230) is administered as a subcutaneous injection designed to reduce the production of lipoprotein(a), potentially improving quality of life by reducing the burden of regular apheresis treatments.
Summary
Both ongoing clinical trials are concentrated in Germany and focus on the same investigational medication, pelacarsen (TQJ230). The trials address different but related aspects of treatment for patients with elevated lipoprotein(a) levels. One study examines long-term safety for patients who have already received the medication, while the other investigates whether pelacarsen can reduce the frequency of apheresis procedures in patients currently undergoing regular treatment. Together, these studies represent a comprehensive approach to understanding both the effectiveness and safety profile of pelacarsen as a potential alternative or complement to lipoprotein apheresis. The concentration of both trials in Germany reflects the country's established infrastructure for apheresis treatment and patient populations with this specific condition.
