Phase 3 Interstitial Lung Disease Trial, Completed

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:

• Children and adolescents between 6 and 17 years old at the time of the second study visit.
• A parent or guardian (and the child, where appropriate) must have signed and dated a consent form before the trial begins.
• Both boys and girls are eligible; girls who could become pregnant must either practice complete abstinence from any sexual activity that could result in pregnancy, or use a highly effective form of birth control combined with a barrier method, starting 28 days before treatment and continuing until 3 months after the last dose.
• People who have signs of a scarring lung disease (fibrosing interstitial lung disease) visible on a detailed CT scan of the lungs taken within 12 months before the first study visit, confirmed by an independent review.
• People whose lungs are still functioning at or above 25% of the expected level for their age and size, based on a breathing test called a Forced Vital Capacity (FVC) test.
• People whose lung disease is considered clinically significant by the doctor, based on at least one of the following: a Fan score of 3 or higher; a decline in breathing capacity of 5–10% accompanied by worsening symptoms; a decline in breathing capacity of 10% or more; increased scarring visible on a CT scan; or other signs of worsening lung disease such as needing more oxygen or a drop in the lung's ability to transfer gases.

Who may not be able to join:

• People whose liver enzyme levels (AST and/or ALT) are more than 1.5 times the upper limit of normal at the first study visit.
• People whose bilirubin levels are more than 1.5 times the upper limit of normal at the first study visit.
• People whose kidneys are not filtering blood well enough, specifically a creatinine clearance below 30 mL/min as measured by a standard formula at the first study visit.
• People with a known long-term liver condition (such as any level of hepatic impairment classified as Child Pugh A, B, or C).
• People who have previously been treated with the drug nintedanib.
• People who have taken another experimental treatment within 1 month or 5 half-lives of the drug (whichever is shorter, but at least 1 week) before the second study visit.
• People with significant high blood pressure in the lungs (pulmonary arterial hypertension), including those with a history of serious right heart failure, a very low cardiac output measured by a right heart procedure, or those currently receiving certain intravenous medications for this condition.
• People with other significant lung abnormalities, as determined by the treating doctor.
• People with severe, uncontrolled high blood pressure in the 6 months before the first study visit (specific blood pressure thresholds differ for children aged 6–12 and teenagers aged 13–17; confirm with trial site).
• People who have had a heart attack within 6 months of the first study visit.
• People who have had unstable chest pain (angina) within 6 months of the first study visit.
• People with a known genetic tendency to bleed.
• People who require certain blood-thinning medications (such as full-dose anticoagulants or high-dose antiplatelet drugs); note that low-dose preventive use of some of these medicines may be permitted (confirm with trial site).
• People who have had a bleed in the brain within 12 months of the first study visit.
• People who have had coughing up blood, blood in the urine, active stomach or intestinal bleeding or ulcers, or a major injury or surgery within 3 months of the first study visit.
• People whose blood clotting test results are significantly outside the normal range at the first study visit.
• People who have had a blood clot, stroke, or mini-stroke (transient ischemic attack) within 12 months of the first study visit.
• People with a known allergy or sensitivity to the trial medication or any of its ingredients, including soya lecithin.
• People with a known allergy to peanuts or soya.
• People with another illness that, in the doctor's opinion, could interfere with the trial or put the person at risk.
• People whose life expectancy from any condition other than the lung disease is less than 2.5 years, as assessed by the doctor.
• Girls who are pregnant, breastfeeding, or planning to become pregnant during the trial.
• People who are unwilling or unable to follow the trial procedures, including taking the study medication as directed.
• People who have a diagnosed growth disorder (such as growth hormone deficiency or certain genetic conditions linked to short stature, for example Turner Syndrome or Noonan Syndrome), or who have been treated with growth hormone therapy within 6 months before the second study visit; however, people with short stature the doctor believes is caused by steroid (glucocorticoid) therapy may still be considered.
• People who weigh less than 13.5 kg at the first study visit.

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