Consider a new clinical trial
for pulmonary arterial
hypertension.
The TROPOS Study is evaluating the safety of an investigational study drug and whether it may stop the worsening of pulmonary arterial hypertension (PAH), a rare form of high blood pressure in the lungs. If you still have symptoms even with available treatments, this clinical trial may be an option for you.
The study drug is given by subcutaneous (under the skin) injection in the abdomen every 4 weeks
at the trial site.
The clinical trial will last up to 2 years and include about 32 visits to a clinical site.
*The trial team can discuss any other additional criteria with you.
*The trial team can discuss any other additional criteria with you.
If you qualify and decide to take part, you will receive:
Please know that your safety while participating in the TROPOS Study is our highest priority. Trial team members are available to discuss any questions or concerns you may have at any point throughout the clinical trial. They can also inform you about COVID-19 safety protocols.
Your participation in any clinical trial is voluntary, and you are always free to withdraw at any time for any reason. Your privacy will be maintained throughout the trial, and all personal and medical information shared will be kept confidential.
PAH is a rare form of high blood pressure in the lungs. It is caused by a narrowing or thickening of small blood vessels inside the lungs that blocks the flow of blood through them. This forces the heart to work harder to pump blood through those vessels which can weaken the heart muscle. The symptoms of PAH severely affect a patient’s quality of life.
Symptoms include:
The exact cause of most PAH is unknown, but in some cases the condition is inherited.
There is no cure for PAH, but there are treatments available to help manage the symptoms and slow the progression of the disease.
The exact cause of most PAH is unknown, but in some cases the condition is inherited.
There is no cure for PAH, but there are treatments available to help manage the symptoms and slow the progression of the disease.
Travel and reimbursement support will be provided. Please ask the trial staff for more information.
This section will help answer some important questions you may have.
Why is this clinical trial being conducted?
The clinical trial is evaluating the safety of an investigational drug and whether it may stop the worsening of a type of high blood pressure involving the blood vessels that go to the lung, called pulmonary arterial hypertension, or PAH.
How is the study drug administered?
The investigational study drug is given by subcutaneous (under the skin) injection in the abdomen every 4 weeks at the trial site.
What is a placebo?
A placebo looks like the investigational study drug but contains no active drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing.
During the 24-week Treatment Period of this clinical trial, you will have a 2 in 3 (67%) chance of receiving the study drug, and a 1 in 3 (33%) chance of receiving a placebo. If you qualify and decide to participate in the 72-week Extension Period of this clinical trial, all participants will be eligible to receive the active study drug. You will also continue taking your current PAH medication(s) during the clinical trial.
How long will my participation in the clinical trial last?
The clinical trial will last up to 2 years and include about a total of 32 visits to the trial site. This is inclusive of an initial 24-week Treatment Period followed by a 72-week Extension Period.
How do I decide if this clinical trial is right for me?
Deciding to participate in this, or any, clinical trial is a personal decision. Before volunteering for a clinical trial, you should talk to your doctor and read about the clinical trial process to ensure you understand the risks – and your rights. Additionally, before making your decision, the trial team will review all aspects of the clinical trial with you. If you decide to participate, you will be given a document called an Informed Consent Form that provides, in writing, information on the clinical trial’s purpose, possible benefits and risks, assessments, procedures, etc. No trial-related procedures can be done until you sign the Informed Consent Form. You will also have the opportunity to ask the trial team questions so you can decide if participating is right for you.
What happens to my personal information?
The information you provide will not be shared with anyone who is not directly associated with the TROPOS Study without your permission, except as required by law or as set forth in the Informed Consent Form, the document you would sign before participating in the clinical trial. The information collected during the trial is stored using codes that will not directly identify you.
Can I leave the clinical trial early?
Yes, participation in clinical trials is always voluntary. If you decide to participate, you are free to withdraw at any time, for any reason, without any penalty or effect on your future medical care. If you do decide to leave the clinical trial early, you should talk to your trial doctor about leaving so that they can schedule a final evaluation.
Will I get paid to participate?
No. However, all clinical trial-related care and the investigational study drug will be provided at no cost. You will be reimbursed (paid back) for your transportation costs related to the clinical trial. The trial team can provide more information about this.
Do I need my doctor’s permission to participate?
No, your doctor does not have to give you permission to participate. However, you are welcome to talk to your doctor about participating in the TROPOS Study. With your permission, the trial doctor can keep your regular doctor updated about your condition during the clinical trial.
What is a clinical trial?
A research study, also known as a clinical trial, is a scientific study that evaluates the safety and effectiveness of an investigational study drug as well as how your body processes that drug. Qualified doctors, nurses, and other medical professionals are responsible for conducting the clinical trial.
It is only through the completion of clinical trials that study drugs can be evaluated and, if proven safe and effective, approved for a particular use. Different regulatory bodies in different countries (such as the US Food and Drug Administration [FDA]) will provide this approval after a thorough review. In order to ensure that a clinical trial is ethical and that participants’ rights and safety are protected, Institutional Review Boards (IRBs) or Ethics Committees (ECs) review the detailed plans and goals for the trial.
During the informed consent process, the trial staff will inform you about the possible benefits and risks of being in the trial. The staff will closely monitor your symptoms and overall health throughout the trial and share any new information that becomes available.
What is a study drug?
A study drug is a medication that has not been approved for prescription use by regulatory or health authorities, such as the FDA or European Medicines Agency (EMA).
Who can participate in a clinical trial?
Only participants who meet all the required eligibility criteria for the clinical trial may take part. The trial team will review your medical history and current medical status against the eligibility criteria to determine if you are eligible to participate. You may also be asked to provide information from your medical records to help the trial team determine whether you may be eligible.
Who is conducting the TROPOS Study?
Keros Therapeutics, Inc., a biopharmaceutical company headquartered in Lexington, Massachusetts, is conducting this clinical trial.
©2023 Keros Therapeutics, Inc.
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