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Nintedanib for Interstitial Lung Disease
Study Summary
This trial is for children and adolescents with interstitial lung disease that causes lung fibrosis, who either took part in a previous study or are 6-17 years old with fibrosing ILD. The purpose is to see how well nintedanib, a medicine used to treat different types of lung fibrosis in adults, is tolerated in children and adolescents. All participants take nintedanib capsules twice a day and will be in the study for at least 2 years.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am not pregnant, nursing, or planning to become pregnant during the trial.I need or want to take medication that may not be safe with the trial.I am willing and able to follow the trial procedures and take the study medication.If you were in the InPedILD® study and did not follow the rules for taking the study medication or attending study visits, you may not be able to participate in this study. However, the doctor may still consider you for the study if they think it is safe and helpful for you.New patients must have a lung function measurement called Forced Vital Capacity (FVC) of at least 25% at their second visit.I have severe PAH with evidence of heart issues or need strong medication.I have severe or uncontrolled high blood pressure, had a heart attack, or unstable angina recently.I stopped my previous trial treatment early due to side effects.I have been diagnosed with fibrosing ILD in the last year.I have a growth disorder or have been treated with growth hormone in the last 6 months.I have worsening lung disease symptoms or test results.I have a high risk of bleeding due to genetic factors, medication use, recent significant bleeding events, or recent major injury/surgery.I am committed to using effective birth control or practicing abstinence as required.You have not received any experimental treatments within the past month, or within five times the duration it takes for the treatment to leave your body, unless it was part of the InPedILD® trial.Your kidney function is very low, as measured by eGFR, at your first visit.Your liver enzymes (AST and ALT) are more than 1.5 times the normal level.Your bilirubin levels are higher than 1.5 times the upper limit of normal at the first visit.You are allergic to the trial medication or any of its parts, like soya lecithin.I have chronic liver disease.My doctor thinks I have more than 2.5 years to live, not counting my lung disease.I weigh less than 13.5 kg.If you have a known allergy to peanuts or soy, you cannot participate.I am between 6 and 17 years old.
- Group 1: Patients rolling over from the InPedILD® study
- Group 2: Patients newly enrolled in this study
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How do I sign up for this experiment?
"Researchers are looking for 60 individuals, aged 6 to 17, who have been diagnosed with pneumonia and interstitial. Additionally, it is mandatory that potential participants meet the following requirements: Visit 2 Children and adolescents 6 to 17 years old., Signed and dated written informed consent and assent, where applicable, in accordance with ICH-GCP and local legislation prior to admission to the trial., Male or female patients. Female of childbearing potential (WOCBP1) must confirm that sexual abstinence is standard practice and will be continued until 3 months after last drug intake, or be ready and able to use a highly effective method of birth"
Is the age limit for this experiment 18 years or older?
"28 studies are available for children under the age of 18 while 288 exist for adults over 65. The current study aims to test subjects aged 6 to 17 years old specifically."
Are we still enrolling people in this experiment?
"This clinical trial is actively searching for participants, according to the information on clinicaltrials.gov. The trial was first posted on 4/4/2022 and was most recently updated on 11/2/2022."
Is Nintedanib (Ofev®) generally well-tolerated by patients?
"Nintedanib (Ofev®) has been given a safety score of 3. This is based on it being a Phase 3 trial, which provides evidence of the medication's efficacy as well as rounds of data supporting its safety."
How many individuals are included in this experiment?
"Yes, if you consult clinicaltrials.gov, you'll see that this study is currently enrolling patients. This trial was originally posted on April 4th, 2022 and has been updated as recently as November 2nd, 2022. The aim is to enroll 60 patients from 9 different hospitals or clinics."
How many places are conducting this experiment?
"At this moment, 9 hospitals are running this clinical trial. They are Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center in Pittsburgh, BC Children's Hospital in Vancouver, and Weill Cornell Medicine in New york. There are also 6 other locations."
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