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 aged 18 or older who are able to give written consent before any study procedures begin
• People who have been diagnosed with pulmonary arterial hypertension (high blood pressure in the lungs) or pulmonary hypertension related to interstitial lung disease (ILD-PH), confirmed by a specific heart pressure test called a right heart catheterisation
• People whose pulmonary hypertension causes moderate symptoms — classified by doctors as WHO Functional Class II or III (meaning symptoms occur with some or most physical activity)
• People whose right heart catheterisation results meet specific pressure and resistance measurements set out by the trial (confirm exact values with trial site)
• People who are on a stable treatment plan for their pulmonary hypertension or ILD-PH before joining
• Women who could become pregnant must agree to use highly effective contraception as defined by the trial protocol
• Male participants must follow the contraception guidelines set out in the trial protocol
• People who are able to communicate clearly with the study team and are willing to complete all study requirements
• People who are able to swallow tablets
• People whose breathing test (lung function) results meet specific criteria depending on whether they have PAH or ILD-PH (confirm details with trial site)
• PAH participants only: people who have had a specific lung scan (VQ scan or equivalent) showing no significant blood clots in the lungs
• People whose heart tracing (ECG) results are within acceptable ranges for heart rate, heart rhythm, and specific electrical intervals, as assessed by the study doctor
• People who weigh more than 50 kg and have a body mass index (BMI) between 19 and 36 at both the screening and baseline visits
• People who can walk between 100 and 550 metres in a 6-minute walk test, with two consistent results taken during the screening and baseline period

Who may not be able to join:

• People diagnosed with pulmonary hypertension types classified as WHO Groups 2, 4, or 5
• People with specific subtypes of PAH, including HIV-related PAH, PAH linked to high blood pressure in the liver (portal hypertension), schistosomiasis-related PAH, or a rare condition affecting the lung veins or capillaries
• People who test positive for hepatitis B, hepatitis C (unless successfully treated with confirmed clearance), or HIV
• People with a known allergy or sensitivity to the study drug (ROC-101) or any of its ingredients
• People who have had a cancer diagnosis in the last 5 years, with some exceptions such as certain minor skin cancers that have been fully removed or treated (confirm with trial site)
• People with other serious ongoing medical conditions that the study doctor believes could affect safe participation
• People who have taken part in another clinical trial involving an experimental treatment within 4 weeks before the baseline visit (or longer, depending on the previous drug — confirm with trial site)
• People who have had major surgery within 8 weeks before the baseline visit, or who have major surgery planned during the study
• People who have previously had a heart or heart-lung transplant, who are on a transplant waiting list, or who have had a lung removed
• Women who are pregnant or breastfeeding
• Male participants who do not agree to follow the trial's contraception guidelines
• People with uncontrolled high blood pressure (blood pressure too high at rest during screening and baseline visits)
• People with very low blood pressure at the screening or baseline visit
• People with a history of significant fluid around the heart or constrictive heart conditions confirmed on heart ultrasound (echocardiogram)
• People for whom the right heart catheterisation procedure is considered unsafe by the study doctor
• People who have had a stroke within 3 months (120 days) before screening begins
• People with a history of certain types of heart muscle disease (restrictive, constrictive, or congestive cardiomyopathy)
• People whose heart pumping function (left ventricular ejection fraction) is below 50%, or who have certain levels of heart stiffness, confirmed on a recent heart ultrasound
• People who have had a heart attack, heart procedure, bypass surgery, or chest pain from heart disease within the past 6 months
• People who have had a sudden worsening of heart failure (left or right side) within 90 days before the baseline visit
• People with more than mild leaking or narrowing of certain heart valves, as seen on the screening heart ultrasound
• People who started or stopped general supportive treatments for pulmonary hypertension (such as oxygen, blood thinners, or digoxin) within 30 days before screening
• People requiring very high levels of supplemental oxygen (more than 10 litres per minute) with low blood oxygen levels
• People who have received certain intravenous heart support medications within 30 days before screening
• People who have had a specific heart procedure (atrial septostomy) within 180 days before screening
• People with a history of high pressure in the liver's blood supply (portal hypertension) or chronic liver disease
• People with severe untreated sleep apnoea (where breathing repeatedly stops during sleep, with an index score above 30)
• People who currently smoke tobacco or cannabis daily
• People who currently misuse alcohol or use illicit drugs
• People with pulmonary hypertension caused by severe chronic obstructive lung disease, combined pulmonary fibrosis and emphysema, or whose lung function test results fall below specific thresholds set by the trial
• People with certain abnormal blood test results at screening
• People with a history of severe kidney disease, including kidney failure requiring dialysis
• People who have recently started (within 90 days before baseline) a cardiac or pulmonary rehabilitation exercise programme, or who plan to start one during the study — although people already in a stable, ongoing maintenance programme may still be eligible (confirm with trial site)
• People currently taking, or planning to take during the study, certain medications that interact with specific liver enzymes (CYP2D6 or CYP1A2) and have a narrow range of safe dosing — such as nortriptyline, venlafaxine, or amitriptyline (confirm full list with trial site)
• People with a history or current signs of poor heart function (confirm details with trial site)
• People who plan to donate blood at any point after signing the consent form and within 28 days after their last dose of the study drug

For the extension period of the trial, additional criteria apply, including completing the main 24-week study period, a negative pregnancy test for women who could become pregnant, and continued agreement to contraception guidelines. People who stopped the main study early due to a side effect from the study drug, or who are pregnant, breastfeeding, or intending to conceive, would not be eligible for the extension period.

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