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Study on Sotatercept for Children with Pulmonary Arterial Hypertension Receiving Standard Care

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Pulmonary Arterial Hypertension (PAH), which is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. The trial is investigating a treatment called sotatercept, also known by its code name MK-7962. Sotatercept is a solution for injection and is being tested to see how safe and tolerable it is for children aged 1 to less than 18 years who are already receiving standard care for PAH.

The purpose of the study is to evaluate the safety and tolerability of sotatercept over a period of 24 weeks. Participants will receive sotatercept through an injection under the skin, and the study will monitor how the body processes the medication. The trial will also observe any side effects that may occur during the treatment period. Throughout the study, various health parameters will be checked, including blood tests and blood pressure measurements, to ensure the well-being of the participants.

This study aims to provide valuable information on how sotatercept works in children with PAH and whether it can be a safe addition to their current treatment. The trial will help researchers understand the potential benefits and risks of using sotatercept in this young population, contributing to the development of better treatment options for PAH in children.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be informed about the trial's objectives, which include evaluating the safety and tolerability of the medication sotatercept over a period of 24 weeks.
The participant will be required to provide consent and confirm their eligibility based on specific criteria, such as having a documented diagnosis of pulmonary arterial hypertension (PAH) and being on stable doses of background PAH therapy.
Step 2
Medication administration
The participant will receive sotatercept, which is a solution for injection administered subcutaneously. The exact dosage and frequency will be determined by the study protocol and communicated to the participant by the study team.
Step 3
Monitoring and assessments
Throughout the 24-week treatment period, the participant will undergo regular monitoring to assess the serum trough concentration of sotatercept and other pharmacokinetic parameters.
The participant will also have laboratory tests to measure various blood parameters, such as hemoglobin, hematocrit, and platelet count, on specific days (21, 42, 63, 84, 105, and 126).
Blood pressure and other health indicators will be checked at regular intervals to ensure the participant's safety.
Step 4
Evaluation of outcomes
The study will evaluate primary outcomes, including the percentage of participants experiencing adverse events and those who discontinue the study drug due to adverse events.
Secondary outcomes will include changes in physical performance, heart function, and quality of life measures from the baseline.
Step 5
Completion of the study
After completing the 24-week treatment period, the participant will have a final assessment to evaluate the overall effects of the treatment.
The participant will be informed about the next steps and any follow-up requirements after the study concludes.

Who can join the trial?

6 criteria

Must have a documented diagnosis of pulmonary arterial hypertension (PAH), which is high blood pressure in the lungs, confirmed by a test called right heart catheterization (RHC) done at any time before the screening.
Must be on a stable dose of current PAH treatments, which may include medications like phosphodiesterase-5 (PDE5) inhibitors, endothelin receptor antagonists (ERAs), soluble guanylate cyclase stimulators (sGCS), or prostanoids.
If male, must agree to either abstain from heterosexual intercourse or use contraception during the study and for at least 16 weeks after the last dose, unless confirmed to be unable to produce sperm.
If female, must either not be of childbearing potential or use a highly effective contraceptive method or abstain from heterosexual intercourse during the study and for at least 16 weeks after the last dose.
If male, must agree not to donate blood or sperm during the study and for 16 weeks after the last dose.
If female, must agree not to donate blood, eggs, or ovum during the study and for at least 16 weeks after the last dose.

Who cannot join the trial?

15 criteria

Patients with other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with a history of allergic reactions to similar medications.
Patients who are unable to follow the study procedures.
Patients with certain heart conditions that could be affected by the study medication.
Patients with severe liver or kidney problems.
Patients who are taking medications that might interact with the study drug.
Patients with a history of drug or alcohol abuse.
Patients with uncontrolled high blood pressure.
Patients with certain infections that could affect the study results.
Patients who have had a recent surgery or are planning to have surgery during the study.
Patients with a history of cancer, unless it has been in remission for a certain period.
Patients with certain blood disorders that could affect the study.
Patients who have been diagnosed with certain autoimmune diseases.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Hopital Beaujon
Verified
Clichy, France
Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain

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Investigated drugs

Sotatercept (MK-7962) is being studied to see how safe and tolerable it is for children aged 1 to less than 18 years who have pulmonary arterial hypertension (PAH). This medication is being tested to understand how it behaves in the body over a period of 24 weeks. The study aims to find out if it can be safely used alongside the standard treatments that these children are already receiving for their condition.

Sotatercept

What is already known about the treatment

Sotatercept – This medication is administered via injection and is currently being studied in clinical trials for its safety and effectiveness in treating pulmonary arterial hypertension (PAH) in children. It is not yet widely used in medical practice, as it is still under investigation. Sotatercept is primarily indicated for PAH, a condition characterized by high blood pressure in the arteries of the lungs. At the molecular level, it works by binding to specific proteins involved in the regulation of blood vessel growth and function, potentially reducing the abnormal blood vessel changes seen in PAH. It is classified pharmacologically as a receptor fusion protein.

Investigated diseases

Pulmonary arterial hypertension – This is a condition characterized by high blood pressure in the arteries that supply the lungs. It occurs when the small arteries in the lungs become narrowed or blocked, making it harder for blood to flow through them. As a result, the heart has to work harder to pump blood through these arteries, which can lead to heart strain and enlargement. Over time, this increased pressure can cause symptoms such as shortness of breath, fatigue, dizziness, and swelling in the ankles or legs. The disease can progress gradually, with symptoms worsening as the pressure in the pulmonary arteries continues to rise. It is a chronic condition that requires ongoing management to help control symptoms and improve quality of life.