Phase 2 Pulmonary Hypertension Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been clinically diagnosed with pulmonary hypertension associated with interstitial lung disease (PH-ILD) — a condition involving high blood pressure in the lungs combined with scarring or damage to lung tissue.
• People who are willing and able to give their own informed consent to participate.
• People aged 18 to 85 years at the time of signing the consent form.
• People who agree to use birth control methods specified by the study protocol during the trial period — males with a partner who could become pregnant must continue this for at least 96 hours after stopping the study drug; females who could become pregnant must continue for 30 days after their last dose. Women who are post-menopausal (no periods for at least 12 months with no other medical explanation), or who have had a hysterectomy, removal of both ovaries or fallopian tubes, or tubal ligation at least 6 weeks before screening, or who have a condition that prevents pregnancy, are not required to use contraception.
• People who have a confirmed interstitial lung disease diagnosis based on a high-resolution chest CT scan taken within 180 days before or at screening, or based on a historical surgical or tissue biopsy sample.
• People who have undergone a right heart catheterisation (a procedure to measure pressure in the heart and lungs) during the screening period, showing specific pressure and resistance measurements that meet the trial's required values (confirm exact values with the trial site).
• People who can walk between 100 and 500 metres in a 6-minute walk test at the start of the study.
• People who agree to have a repeat right heart catheterisation, chest CT scan, and MRI before the study ends.
• People already on long-term treatment for their underlying lung disease (such as nintedanib, pirfenidone, or immune-suppressing medications) who have been on a stable, optimised dose for at least 30 days before screening and have been receiving that treatment for at least 90 days.
• People on supportive medications (such as inhalers for asthma) who have been on stable doses for at least 30 days before screening.
• People who, in the investigator's opinion, are able to consent for themselves and communicate with the study team (interpreters may be used if needed), and who agree to attend all study visits and be reachable by phone.
• People whose routine blood test results are within normal ranges or no more than 1.5 times the upper limit of normal.
• People whose lung function tests show a forced vital capacity (a measure of how much air can be breathed out) below 70% of what is expected for their age and size, and a carbon monoxide diffusion capacity (a measure of how well the lungs transfer gases) below 70%, within a specific range, measured according to recognised standards.
• People with certain connective tissue diseases — such as scleroderma, lupus, Sjögren's disease, inflammatory muscle diseases, or rheumatoid arthritis — may be included, though the trial limits this group to no more than 20% of total participants.
• People who test negative for hepatitis B and hepatitis C at the screening visit.

Who may not be able to join:

• People who have another form of pulmonary hypertension that is not related to interstitial lung disease, including conditions such as blood clots in the lungs, untreated or poorly treated sleep apnea, HIV infection, or use of methamphetamine or appetite-suppressing drugs.
• People who have significant left-sided heart disease within the past 6 months, such as a weakened heart pumping less than 40% of its capacity, more than mild heart valve problems, or abnormally high pressure on the left side of the heart.
• People who have three or more of the following risk factors for left-sided heart problems: a body mass index (BMI) of 30 or above; poorly controlled diabetes; a significant history of coronary (heart) artery disease within the past 6 months (such as a heart attack, coronary stent or bypass surgery, or significant artery blockage).
• People who require more than 10 litres per minute of supplemental oxygen at rest.
• People who have received certain approved pulmonary hypertension treatments — including phosphodiesterase-5 inhibitors, soluble guanylate cyclase stimulators, endothelin receptor antagonists, or oral or intravenous prostacyclin therapies — within 60 days of randomisation or within 5 half-lives of those drugs. Inhaled prostacyclin (such as inhaled treprostinil) at a stable dose for at least 30 days before screening is permitted.
• People who are currently using certain medications that strongly affect how the body processes drugs through the CYP3A4 liver enzyme — including some antifungals, certain HIV medications, some antibiotics, and herbal products such as St. John's Wort, among others (confirm the full list with the trial site).
• People who have had a recent worsening of their lung disease or an active lung or upper respiratory tract infection within 4 weeks of randomisation.
• People with any currently active cancer, excluding minor skin cancers such as basal or squamous cell carcinoma. People with a history of cancer likely to cause serious problems or require major treatment within the coming year are also excluded.
• People with advanced chronic kidney disease (stage IV or worse, meaning kidney function is severely reduced) or signs of sudden kidney injury.
• People with a history of congenital (present from birth) heart disease, regardless of whether it has been treated or surgically corrected.
• People who have used tobacco, e-cigarettes, nicotine products, or marijuana, or who have a significant history of drug or alcohol misuse within 6 months of screening.
• People who have had an acute blood clot in the lungs (pulmonary embolism) within 90 days of screening.
• People who have participated in a pulmonary rehabilitation programme within 90 days of screening.
• People who have taken part in another clinical trial or used an experimental drug, device, or therapy within 30 days or 5 half-lives (whichever is longer) before the first dose of the study drug.
• People with a BMI of 40 or above.
• People with uncontrolled high blood pressure — specifically a systolic reading above 160 mmHg or diastolic above 100 mmHg — during the screening period. A one-time re-screening may be permitted after blood pressure medication has been adjusted and stabilised for at least 4 weeks.
• People with another illness that gives them a life expectancy of less than 6 months at screening.
• People whom the investigator believes will be unable to fully complete the study, for any reason including difficulty following study procedures or relevant medical or psychiatric conditions.
• People who, in the investigator's opinion, are highly likely to need a lung transplant within 4 months of being enrolled in the trial.
• People with a history of moderate or severe liver disease or problems with blood clotting related to liver function.
• People who are pregnant or currently breastfeeding.
• People with untreated sleep apnea that is worse than mild (more than 5 to 14.9 breathing interruptions per hour). Treated sleep apnea is permitted.
• People who have had an allergic or severe reaction to mirivadelgat (the study drug) or any of its ingredients.
• People who have previously been given mirivadelgat.
• People whose blood test results at screening show: haemoglobin (red blood cell measure) below 10 g/dL; white blood cell count below 3,000 per microlitre; platelet count below 70,000 per microlitre; or a kidney filtration rate below 30 mL/min/1.73m², or signs of acute kidney injury.

Important: Always verify eligibility with the trial site directly before applying.