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A Study to Find Out How Nintedanib is Taken up in the Body and How Well it is Tolerated in Children and Adolescents With Interstitial Lung Disease (ILD)

Study Purpose

The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Children and adolescents 6 to 17 years old at Visit 2.
  • - Signed and dated written informed consent and assent, where applicable, in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
  • - Male or female patients.
Female of childbearing potential (WOCBP) 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 control per International Conference on Harmonisation (ICH) M3 (R2) that results in a low failure rate of less than 1% per year when used consistently and correctly, in combination with one barrier method, from 28 days prior to initiation of study treatment, during treatment and until 3 months after last drug intake. Sexual abstinence is defined as abstinence from any sexual act that may result in pregnancy. A list of contraception methods meeting these criteria is provided in the parental information.
  • - Patients with evidence of fibrosing Interstitial Lung Disease (ILD) on High-Resolution Computed Tomography (HRCT) within 12 months of Visit 1 as assessed by the investigator and confirmed by central review.
  • - Patients with Forced Vital Capacity (FVC)% predicted ≥25% at Visit 2.
[Note: Predicted normal values will be calculated according to GLI (Global Lung Initiative)]
  • - Patients with clinically significant disease at Visit 2, as assessed by the investigator based on any of the following: - Fan score ≥3, or.
  • - Documented evidence of clinical progression over time based on either.
  • - a 5-10% relative decline in FVC% predicted accompanied by worsening symptoms, or.
  • - a ≥10% relative decline in FVC % predicted, or.
  • - increased fibrosis on HRCT, or.
  • - other measures of clinical worsening attributed to progressive lung disease (e.g. increased oxygen requirement, decreased diffusion capacity).

Exclusion Criteria:

  • - Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT)>1.5 x Upper Level of Normal (ULN) at Visit 1.
  • - Bilirubin >1.5 x ULN at Visit 1.
  • - Creatinine clearance <30 mL/min calculated by Schwartz formula at Visit 1.
[Note: Laboratory parameters from Visit 1 have to satisfy the laboratory threshold values as shown above. Visit 2 laboratory results will be available only after randomization. In case at Visit 2 the results do no longer satisfy the entry criteria, the Investigator has to decide whether it is justified that the patient remains on study drug. The justification for decision needs to be documented. Laboratory parameters that are found to be abnormal at Visit 1 are allowed to be re-tested (once) if it is thought to be a measurement error (i.e. there was no abnormal result of this test in the recent history of the patient and there is no related clinical sign) or the result of a temporary and reversible medical condition, once that condition is resolved.]
  • - Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment) at Visit 1.
  • - Previous treatment with nintedanib.
  • - Other investigational therapy received within 1 month or 5 half-lives (whichever is shorter but ≥1 week) prior to Visit 2.
  • - Significant pulmonary arterial hypertension (PAH) defined by any of the following: - Previous clinical or echocardiographic evidence of significant right heart failure.
  • - History of right heart catheterization showing a cardiac index ≤2 l/min/m² - PAH requiring parenteral therapy with epoprostenol/treprostinil.
  • - In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
  • - Cardiovascular diseases, any of the following: - Severe hypertension, uncontrolled under treatment, within 6 months of Visit 1.
Uncontrolled hypertension is defined as.
  • - In children 6 to ≤12 years old: ≥95th percentile + 12 mm Hg or ≥140/90 mm Hg (whichever is lower) (systolic or diastolic blood pressure equal to or greater than the calculated target value) - In adolescents 13 to 17 years old: systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg.
  • - Myocardial infarction within 6 months of Visit 1.
  • - Unstable cardiac angina within 6 months of Visit 1.
  • - Bleeding risk, any of the following: - Known genetic predisposition to bleeding.
  • - Patients who require.
  • - Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin) - High dose antiplatelet therapy [Note: Prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g. enoxaparin 4000 I.
U. s.c. per day), as well as prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/day, or clopidogrel at 75 mg/day, or equivalent doses of other antiplatelet therapy) are not prohibited.]
  • - History of haemorrhagic central nervous system (CNS) event within 12 months of Visit 1.
  • - Any of the following within 3 months of Visit 1: - Haemoptysis or haematuria.
  • - Active gastro-intestinal (GI) bleeding or GI - ulcers.
  • - Major injury or surgery (investigator's judgment) - Any of the following coagulation parameters at Visit 1: - International normalized ratio (INR) >2.
  • - Prolongation of prothrombin time (PT) by >1.5 x ULN.
  • - Prolongation of activated partial thromboplastin time (aPTT) by >1.5 x ULN.
  • - History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Visit 1.
  • - Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).
  • - Patients with documented allergy to peanut or soya.
  • - Other disease that may interfere with testing procedures or in the judgment of the investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
  • - Life expectancy for any concomitant disease other than Interstitial Lung Disease (ILD)<2.5 years (investigator assessment).
  • - Female patients who are pregnant, nursing, or who plan to become pregnant while in the trial.
  • - Patients not able or willing to adhere to trial procedures, including intake of study medication.
  • - Patients with any diagnosed growth disorder such as growth hormone deficiency or any genetic disorder that is associated with short stature (e.g. Turner Syndrome, Noonan Syndrome, Russell-Silver Syndrome) and/or treatment with growth hormone therapy within 6 months before Visit 2.
Patients with short stature considered by the investigator to be due to glucocorticoid therapy may be included.
  • - Patients <13.5 kg of weight at Visit 1 (same threshold to be used for male and female patients).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04093024
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Mexico, Norway, Poland, Portugal, Russian Federation, Spain, Ukraine, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lung Diseases, Interstitial
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Nintedanib (Ofev®)

Placebo Comparator: Placebo

Interventions

Drug: - Nintedanib (Ofev®)

Capsule

Drug: - Placebo

Capsule

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital Los Angeles, Los Angeles, California

Status

Active, not recruiting

Address

Children's Hospital Los Angeles

Los Angeles, California, 90027

Children's Hospital Colorado, Aurora, Colorado

Status

Active, not recruiting

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Indianapolis, Indiana

Status

Active, not recruiting

Address

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202

Children's Mercy Hospitals and Clinics, Kansas City, Missouri

Status

Completed

Address

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

Weill Cornell Medicine, New York, New York

Status

Active, not recruiting

Address

Weill Cornell Medicine

New York, New York, 10021

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Active, not recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Pittsburgh, Pennsylvania

Status

Active, not recruiting

Address

Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15224

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Active, not recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Seattle Children's Hospital, Seattle, Washington

Status

Active, not recruiting

Address

Seattle Children's Hospital

Seattle, Washington, 98105

International Sites

Caba, Argentina

Status

Active, not recruiting

Address

Hospital de Pediatría " Prof. Dr. Juan P. Garrahan"

Caba, , C1245AAM

Hospital de Niños Dr. Ricardo Gutierrez, Caba, Argentina

Status

Active, not recruiting

Address

Hospital de Niños Dr. Ricardo Gutierrez

Caba, , C1425EFD

Caba, Argentina

Status

Recruiting

Address

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Caba, , C1426BOR

Site Contact

Gonzalo Pérez Marc

gonzaloperezmarc@gmail.com

+54 11 4776 8084

INSARES, Mendoza, Argentina

Status

Completed

Address

INSARES

Mendoza, , M5500CCG

Women's and Children's Hospital, North Adelaide, South Australia, Australia

Status

Terminated

Address

Women's and Children's Hospital

North Adelaide, South Australia, 5006

Brussels - UNIV HUDERF, Bruxelles, Belgium

Status

Active, not recruiting

Address

Brussels - UNIV HUDERF

Bruxelles, , 1020

Centro Medico Santa Maria, Barra Mansa, Brazil

Status

Active, not recruiting

Address

Centro Medico Santa Maria

Barra Mansa, , 27323240

Hospital da Crianca Santo Antonio, Porto Alegre, Brazil

Status

Recruiting

Address

Hospital da Crianca Santo Antonio

Porto Alegre, , 90035-074

Site Contact

Gilberto Fischer

gbfinter@gmail.com

+55 51 3214-8998

Sao Paulo, Brazil

Status

Completed

Address

Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP

Sao Paulo, , 5403-900

São Bernardo do Campo, Brazil

Status

Recruiting

Address

CEMEC - Centro Multidisciplinar de Estudos Clínicos

São Bernardo do Campo, , 09780-000

Site Contact

Andreia Pez

andreiajdi@hotmail.com

551149304243

Alberta Children's Hospital, Calgary, Alberta, Canada

Status

Recruiting

Address

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8

Site Contact

Ian Mitchell

imitche@ucalgary.ca

403-955-2952

BC Children's Hospital, Vancouver, British Columbia, Canada

Status

Completed

Address

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1

The Hospital for Sick Children, Toronto, Ontario, Canada

Status

Active, not recruiting

Address

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8

Teaching Hospital Motol, Oncology Clinic, Praha 5, Czechia

Status

Active, not recruiting

Address

Teaching Hospital Motol, Oncology Clinic

Praha 5, , 150 06

Aarhus University Hospital, Aarhus N, Denmark

Status

Completed

Address

Aarhus University Hospital

Aarhus N, , 8200

Tampere University Hospital, Tampere, Finland

Status

Completed

Address

Tampere University Hospital

Tampere, , 33520

HOP Intercommunal, Créteil, France

Status

Active, not recruiting

Address

HOP Intercommunal

Créteil, , 94010

HOP Necker, Paris, France

Status

Recruiting

Address

HOP Necker

Paris, , 75015

Site Contact

Rola Abou Taam

rola.aboutaam@aphp.fr

+33 (0)1 71 39 68 83

HOP Armand-Trousseau, Paris, France

Status

Completed

Address

HOP Armand-Trousseau

Paris, , 75571

Charité - Universitätsmedizin Berlin, Berlin, Germany

Status

Recruiting

Address

Charité - Universitätsmedizin Berlin

Berlin, , 13353

Site Contact

Marcus Mall

marcus.mall@charite.de

+49 (30) 450566131

Hamburg, Germany

Status

Recruiting

Address

Hamburger Zentrum für Kinder- und Jugendrheumatologie

Hamburg, , 22081

Site Contact

Ivan Foeldvari

foeldvari@t-online.de

+49 (40) 20923697

Thessaloniki, Greece

Status

Active, not recruiting

Address

General Hospital of Thessaloniki "Ippokrateio"

Thessaloniki, , 54642

Semmelweis University, Budapest, Hungary

Status

Completed

Address

Semmelweis University

Budapest, , 1122

Azienda Ospedaliera Meyer, Firenze, Italy

Status

Recruiting

Address

Azienda Ospedaliera Meyer

Firenze, , 50139

Site Contact

Enrico LOMBARDI

enrico.lombardi@meyer.it

+39 (055) 5662589

Padova, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria di Padova

Padova, , 35128

Site Contact

Stefania ZANCONATO

stefania.zanconato@aopd.veneto.it

+39 (049) 8215658

Osp. Pediatrico Bambin Gesù, Roma, Italy

Status

Recruiting

Address

Osp. Pediatrico Bambin Gesù

Roma, , 00165

Site Contact

Renato Cutrera

renato.cutrera@opbg.net

+39 (06) 68592372

Nuevo León, Mexico

Status

Recruiting

Address

Hospital Universitario Dr Jose Eleuterio Gonzalez

Nuevo León, , 64460

Site Contact

Aquiles Quiroga Rivera

aquirri2@yahoo.com.mx

+52 81 8348 6173

Clinical Research Institute S.C., Tlalnepantla, Mexico

Status

Recruiting

Address

Clinical Research Institute S.C.

Tlalnepantla, , 54055

Site Contact

Marian Rodriguez Alvarado

neumopedcare@gmail.com

+525553627780

Oslo, Norway

Status

Active, not recruiting

Address

Oslo Universitetssykehus HF, Rikshospitalet

Oslo, , N-0372

Warsaw, Poland

Status

Active, not recruiting

Address

Independent Public Teaching Children's Hospital

Warsaw, , 02091

CHULC, EPE - Hospital Dona Estefânia, Lisboa, Portugal

Status

Active, not recruiting

Address

CHULC, EPE - Hospital Dona Estefânia

Lisboa, , 1169-045

CHULN, EPE - Hospital de Santa Maria, Lisboa, Portugal

Status

Active, not recruiting

Address

CHULN, EPE - Hospital de Santa Maria

Lisboa, , 1649-035

Moscow, Russian Federation

Status

Completed

Address

Children's Hematology,Oncology&Immunology na Rogachev,Moscow

Moscow, , 117198

Novosibirsk, Russian Federation

Status

Active, not recruiting

Address

State Novosibirsk Regional Clinical Hospital

Novosibirsk, , 630087

St. Petersburg, Russian Federation

Status

Completed

Address

St. Petersburg State Pediatric University

St. Petersburg, , 194100

Yaroslavl, Russian Federation

Status

Recruiting

Address

State Budget Clinical Healthcare Instit.Yaroslavl Region Central City Hosp.

Yaroslavl, , 150003

Site Contact

Irina Asherova

irina_asherova@mail.ru

+7 4852 74 66 34

Hospital Vall d'Hebron, Barcelona, Spain

Status

Active, not recruiting

Address

Hospital Vall d'Hebron

Barcelona, , 08035

Hospital Virgen del Rocío, Sevilla, Spain

Status

Completed

Address

Hospital Virgen del Rocío

Sevilla, , 41013

Kharkiv, Ukraine

Status

Completed

Address

Regional Children Clinical Hospital, Pulmonology, Kharkiv

Kharkiv, , 61093

Kyiv, Ukraine

Status

Completed

Address

Institute of Phthisiology and Pulmonology n. a. F.G.Yanovsky

Kyiv, , 03680

Zaporizhya, Ukraine

Status

Active, not recruiting

Address

Regional clinical children hospital, Zaporizhya

Zaporizhya, , 69063

Birmingham Children's Hospital, Birmingham, United Kingdom

Status

Active, not recruiting

Address

Birmingham Children's Hospital

Birmingham, , B4 6NH

Edinburgh, United Kingdom

Status

Recruiting

Address

Royal Hospital for Children and Young People

Edinburgh, , EH16 4TJ

Site Contact

Steve Cunningham

Steve.Cunningham@ed.ac.uk

44(0)131 536 0641

Alder Hey Children's Hospital, Liverpool, United Kingdom

Status

Recruiting

Address

Alder Hey Children's Hospital

Liverpool, , L12 2AP

King's College Hospital, London, United Kingdom

Status

Active, not recruiting

Address

King's College Hospital

London, , SE5 9RS