Phase 3 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from the 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 are willing to take part voluntarily and agree to sign a consent form before the study begins
• People aged between 40 and 80 years old (inclusive), of any gender
• People who have been diagnosed with IPF (idiopathic pulmonary fibrosis) according to 2022 international guidelines, confirmed by a specialist review of a chest scan taken within 3 months before screening, or by a lung biopsy if one was done
• People whose breathing test results show a certain ratio of air breathed out in one second compared to total lung capacity (FEV1/FVC ratio of 0.7 or above) (confirm with trial site)
• People whose lung capacity is at least 45% of what would be expected for a healthy person of their age and size
• People whose lungs are transferring at least 30% of the oxygen into the blood compared to what would be expected for a healthy person (with a correction made for haemoglobin levels)
• People who are able to become pregnant or father a child, and who agree to use effective contraception from signing the consent form until 30 days after the last dose of the study drug, and who agree not to donate eggs or sperm during this time
• People who are willing and able to follow the study schedule and attend all required visits, as assessed by the study doctor

Who may not be able to join:

• People whose IPF has significantly worsened in the three months before joining the study, in the opinion of the study doctor
• People whose lung disease is caused by a known reason other than IPF, such as exposure to certain substances at home or work, an autoimmune or connective tissue condition, or a reaction to medication
• People with other lung or chest abnormalities that the study doctor believes could affect the trial results
• People who have had an active infection requiring treatment taken by mouth or through a drip (such as a bacterial, viral, parasitic, or fungal infection) within one month before joining the study
• People who are expected to need a lung transplant during the study period
• People whose life expectancy is less than 6 months
• People who have had a cancer diagnosis within the past 5 years (with the exception of certain localised skin cancers such as basal cell carcinoma)
• People with moderate to severe liver disease (classified as Child-Pugh grade B or C) (confirm with trial site)
• People who have had unstable or worsening heart disease in the six months before screening, including unstable chest pain, a heart attack, heart failure requiring a hospital stay or classed as severe, or serious uncontrolled irregular heart rhythm
• People who are unable to complete a 6-minute walking test or lung function tests, for example due to difficulty cooperating with instructions
• People who are allergic to any ingredient in the study drug (Ifinonate Hydrochloride Tablets) or in pirfenidone tablets
• People who have taken another clinical trial drug within 4 weeks before joining, or within 5 half-lives of that drug — whichever period is longer
• People who are pregnant or breastfeeding
• People who have smoked in the 3 months before screening, or who are unwilling to remain smoke-free during the study
• People who have drunk alcohol heavily in the 6 months before screening — defined as more than 21 units per week on average (where 1 unit equals approximately 360 mL of beer, 150 mL of wine, or 45 mL of spirits)
• People who have misused drugs in the 6 months before screening
• People who have a personal or family history of a heart rhythm condition called long QT syndrome
• People whose blood tests during screening show liver function values above certain limits, specifically total bilirubin more than 1.5 times the upper limit of normal, or certain liver enzymes more than twice the upper limit of normal (confirm with trial site)
• People whose kidney function test during screening shows a filtration rate below 45 mL/min/1.73m² (confirm with trial site)
• People who test positive for HIV antibodies or syphilis at screening
• People with uncontrolled hepatitis B or hepatitis C infection at the time of screening, based on specific blood test results
• People whose heart trace (ECG) during screening shows a particular electrical measurement (QTcF) above 480 milliseconds (confirm with trial site)
• People who have previously taken the study drug (isoniazidine hydrochloride)
• People who have used certain medications in the 4 weeks before joining, including chemotherapy or immune-suppressing drugs, pirfenidone or nintedanib, high-dose steroid tablets (above 15 mg per day of prednisone or equivalent), or certain drugs that strongly affect how the body processes other medications (confirm with trial site for the full list)
• People the study doctor believes have any other condition that could affect their safety, how the drug works in their body, or their ability to complete the study

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