At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Sotatercept (drug)
- How long the study runs
- Study runs about 68 months (dates as stated)
- About the drug or intervention
- Sotatercept — drug: SC injection every 3 weeks (Q3W) of 0.3 mg/kg.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at a medicine called sotatercept in children with pulmonary arterial hypertension (PAH), a condition where the blood pressure in the arteries of the lungs is too high. It is run by Merck Sharp & Dohme LLC. The trial is testing how well the medicine works in children whose PAH has been confirmed by a heart test called right heart catheterisation.
Who can take part
- Has pulmonary arterial hypertension (PAH) confirmed by a right heart catheterisation (a heart test) at any time before screening
- Has one of these types of PAH: PAH with no known cause, inherited PAH, PAH caused by a drug or toxin, PAH linked to connective tissue disease, PAH linked to congenital heart disease (a heart problem from birth) that has been repaired, or PAH with a heart hole found by chance
- Already taking a steady dose of PAH medicine, such as phosphodiesterase-5 (PDE5) inhibitors, endothelin receptor antagonists, soluble guanylate cyclase stimulators, or prostanoids (given under the skin or into a vein)
- Boys must use a condom or avoid sex during the study and for at least 16 weeks after the last dose, and must not donate blood or sperm during this time
- Girls who could become pregnant must use highly effective contraception or avoid sex during the study and for at least 16 weeks after the last dose, and must not donate blood or eggs during this time
Who may not be able to
- Past left-sided heart disease, such as heart valve disease or heart failure
- Severe lung, chest, or diaphragm problems present from birth or childhood (based on the study doctor's opinion)
- History of Eisenmenger syndrome, a Potts shunt, or an atrial septostomy (heart or lung procedures or conditions)
- A heart hole that has not been repaired or is still leaking
- Pulmonary veno-occlusive disease, pulmonary capillary haemangiomatosis, or signs of problems with small lung blood vessels
- PAH linked to portal hypertension (high blood pressure in the liver)
- Known abnormal connections between arteries and veins in the lung, liver, or brain
- Past surgery to remove part or all of a lung
- Untreated sleep apnoea (pauses in breathing during sleep) that is more than mild
- Known tightening of the sac around the heart
- Family history of sudden cardiac death or long QT syndrome (a heart rhythm problem)
- Heart disease symptoms such as a heart attack, heart procedure, or chest pain caused by the heart within 6 months before screening
- A stroke within 3 months before screening
- Has taken sotatercept or luspatercept before, or has had an allergic reaction to any of their ingredients
What taking part involves
- • Taking the study medicine sotatercept (MK-7962) alongside your existing PAH medicines
- • Not stated — ask the trial team about how the medicine is given, how often, and for how long
Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and exactly what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 1 Year to 17 Years
- Who
- All
- Number of participants
- 42
- Started
- 2023-01-19
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for pulmonary arterial hypertension
- • Phase2 - 42 participants
- • The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to \<18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC)
Who can take part?
- • Ages 1 Year to 17 Years
- • Diagnosed with pulmonary arterial hypertension
Where?
- • London - Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to \<18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 1 Year - 17 Years
- Who can join: All genders
What the study is looking for
- ✓Inclusion Criteria
- ✓Documented, historic diagnostic right heart catheterization (RHC) any time before Screening confirming the diagnosis...
- ✓Idiopathic lung arterial hypertension (IPAH)
- ✓Heritable PAH
- ✓Drug/toxin-induced PAH
See the full criteria
Where Is This Study? (1 UK site)
Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500)
London WC1N 3JH, United Kingdom
How to Get in Touch
Toll Free Number
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