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A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)

Primary Purpose

Lung Diseases, Interstitial

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nintedanib (Ofev®)
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases, Interstitial

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

For new patients:

  1. Children and adolescents 6 to 17 years old at Visit 2.
  2. Signed and dated written informed consent and assent, where applicable, in accordance with ICH-GCP and local legislation prior to admission to the trial.
  3. 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 control per 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.
  4. 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.
  5. Patients with Forced Vital Capacity (FVC) % predicted ≥25% at Visit 2.
  6. 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).

    For roll-over patients from the InPedILD® study:

    Only criteria 2 and 3 listed for new patients are applicable with the following additional inclusion criterion:

  7. Patients who completed the InPedILD® trial as planned and who did not permanently prematurely discontinue study treatment.

For patients who prematurely discontinued treatment permanently in 1199-0337 but are potentially eligible and for completed patients from parent trial not able to roll over into the extension trial within 12 weeks following their End of Treatment Visit in the parent trial:

Inclusion criteria for new patients are applicable except criteria 4, and 6 (as eligibility for these criteria has been confirmed already in 1199-0337 and does not need to be repeated) and also except inclusion criterion 1 for completed patients from parent trial not able to roll over within 12 weeks following their End of Treatment Visit in the parent trial.

Exclusion Criteria:

For new patients:

  1. Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) >1.5 x Upper limit of normal (ULN) at Visit 1.
  2. Bilirubin >1.5 x ULN at Visit 1.
  3. Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m² at Visit 1
  4. Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment) at Visit 1.
  5. Other investigational therapy received within 1 month or 5 half-lives (whichever is shorter but ≥1 week) prior to Visit 2 except investigational therapy received in InPedILD® trial.
  6. 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
  7. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
  8. 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
  9. 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
    • 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
  10. History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Visit 1.
  11. Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).
  12. Patients with documented allergy to peanut or soya.
  13. 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.
  14. Life expectancy for any concomitant disease other than ILD <2.5 years (investigator assessment).
  15. Female patients who are pregnant, nursing, or who plan to become pregnant while in the trial.
  16. Patients not able or willing to adhere to trial procedures, including intake of study medication.
  17. Patients who must or wish to take any drug considered likely to interfere with the safe conduct of the trial according to investigator's benefit-risk assessment for the individual patient
  18. 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.
  19. Patients <13.5 kg of weight at Visit 1 (same threshold to be used for male and female patients).

    For roll-over patients from the InPedILD® study:

    Only criteria 11, 12, 13, 15, 16, 17 and 19, listed for new patients are applicable with the following additional exclusion criterion:

  20. Patient not compliant in parent trial (InPedILD®), with trial medication or trial visits, according to investigator's judgement. Roll-over patients may qualify for participation even though other exclusion criteria may have been met during the participation in InPedILD®, if the investigator's benefit-risk assessment for the individual patient remains favorable.

    For patients who prematurely discontinued treatment permanently in 1199-0337 but are potentially eligible and for completed patients from parent trial not able to roll over into the extension trial within 12 weeks following their End of Treatment Visit in the parent trial:

    All exclusion criteria for new patients are applicable. In addition, the following additional exclusion criterion is applicable for patients who prematurely discontinued treatment permanently in 1199-0337:

  21. Patients who experienced drug-related adverse events during parent trial leading to permanent study treatment discontinuation.

Sites / Locations

  • Children's Hospital Los AngelesRecruiting
  • Children's Hospital ColoradoRecruiting
  • Weill Cornell MedicineRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
  • Vanderbilt University Medical CenterRecruiting
  • Hospital de Pediatría " Prof. Dr. Juan P. Garrahan"Recruiting
  • Hospital de Niños Dr. Ricardo GutierrezRecruiting
  • Brussels - UNIV HUDERFRecruiting
  • Serviços Medicos Respirar Sul FluminenseRecruiting
  • Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSPRecruiting
  • BC Children's HospitalRecruiting
  • The Hospital for Sick ChildrenRecruiting
  • Teaching Hospital Motol, Oncology ClinicRecruiting
  • Tampere University HospitalRecruiting
  • HOP IntercommunalRecruiting
  • Charité - Universitätsmedizin BerlinRecruiting
  • Hamburger Zentrum für Kinder- und JugendrheumatologieRecruiting
  • General Hospital of Thessaloniki "Ippokrateio"Recruiting
  • Azienda Ospedaliera MeyerRecruiting
  • Osp. Pediatrico Bambin GesùRecruiting
  • Clinical Research Institute S.C.Recruiting
  • Amsterdam UMC, Locatie AMCRecruiting
  • Oslo Universitetssykehus HF, RikshospitaletRecruiting
  • Independent Public Teaching Children's HospitalRecruiting
  • CHULC, EPE - Hospital Dona EstefâniaRecruiting
  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa MariaRecruiting
  • CHUP, EPE - Centro Materno Infantil do NorteRecruiting
  • Hospital Vall d'HebronRecruiting
  • Hospital Virgen del RocíoRecruiting
  • King's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients rolling over from the InPedILD® study

Patients newly enrolled in this study

Arm Description

Outcomes

Primary Outcome Measures

Incidence of treatment emergent adverse events

Secondary Outcome Measures

Full Information

First Posted
March 10, 2022
Last Updated
July 11, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05285982
Brief Title
A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)
Official Title
An Open-label Trial of the Long-term Safety and Tolerability of Nintedanib Per os, on Top of Standard of Care, Over at Least 2 Years, in Children and Adolescents With Clinically Significant Fibrosing Interstitial Lung Disease (InPedILD®-ON)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
August 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is open to children and adolescents with interstitial lung disease (ILD) that causes lung fibrosis. This is a study for people who took part in a previous study (study 1199-0337, InPedILD™) and for people who are between 6 and 17 years old and have fibrosing ILD. This study tests a medicine called nintedanib. Nintedanib is already used to treat different types of lung fibrosis in adults. The purpose of the study is to find out how well long-term treatment with nintedanib is tolerated in children and adolescents. All participants take nintedanib capsules twice a day. Participants are in the study for at least 6 months or until nintedanib or other treatment options become available outside of this study. During the first 2 years, they visit the study site between 9 and 11 times. Afterwards, they visit the study site every 3 months. The doctors collect information on any health problems of the participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients rolling over from the InPedILD® study
Arm Type
Experimental
Arm Title
Patients newly enrolled in this study
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nintedanib (Ofev®)
Intervention Description
Nintedanib (Ofev®) soft capsules
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events
Time Frame
up to 29 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For new patients: Children and adolescents 6 to 17 years old at Visit 2. 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 control per 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. 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. 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). For roll-over patients from the InPedILD® study: Only criteria 2 and 3 listed for new patients are applicable with the following additional inclusion criterion: Patients who completed the InPedILD® trial as planned and who did not permanently prematurely discontinue study treatment. For patients who prematurely discontinued treatment permanently in 1199-0337 but are potentially eligible and for completed patients from parent trial not able to roll over into the extension trial within 12 weeks following their End of Treatment Visit in the parent trial: Inclusion criteria for new patients are applicable except criteria 4, and 6 (as eligibility for these criteria has been confirmed already in 1199-0337 and does not need to be repeated) and also except inclusion criterion 1 for completed patients from parent trial not able to roll over within 12 weeks following their End of Treatment Visit in the parent trial. Exclusion Criteria: For new patients: Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) >1.5 x Upper limit of normal (ULN) at Visit 1. Bilirubin >1.5 x ULN at Visit 1. Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m² at Visit 1 Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment) at Visit 1. Other investigational therapy received within 1 month or 5 half-lives (whichever is shorter but ≥1 week) prior to Visit 2 except investigational therapy received in InPedILD® trial. 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 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 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 who must or wish to take any drug considered likely to interfere with the safe conduct of the trial according to investigator's benefit-risk assessment for the individual patient 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). For roll-over patients from the InPedILD® study: Only criteria 11, 12, 13, 15, 16, 17 and 19, listed for new patients are applicable with the following additional exclusion criterion: Patient not compliant in parent trial (InPedILD®), with trial medication or trial visits, according to investigator's judgement. Roll-over patients may qualify for participation even though other exclusion criteria may have been met during the participation in InPedILD®, if the investigator's benefit-risk assessment for the individual patient remains favorable. For patients who prematurely discontinued treatment permanently in 1199-0337 but are potentially eligible and for completed patients from parent trial not able to roll over into the extension trial within 12 weeks following their End of Treatment Visit in the parent trial: All exclusion criteria for new patients are applicable. In addition, the following additional exclusion criterion is applicable for patients who prematurely discontinued treatment permanently in 1199-0337: Patients who experienced drug-related adverse events during parent trial leading to permanent study treatment discontinuation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boehringer Ingelheim
Phone
1-800-243-0127
Email
clintriage.rdg@boehringer-ingelheim.com
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Completed
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Hospital de Pediatría " Prof. Dr. Juan P. Garrahan"
City
Caba
ZIP/Postal Code
C1245AAM
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Hospital de Niños Dr. Ricardo Gutierrez
City
Caba
ZIP/Postal Code
C1425EFD
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Brussels - UNIV HUDERF
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
080049616
Email
belgique@bitrialsupport.com
Facility Name
Serviços Medicos Respirar Sul Fluminense
City
Barra Mansa
ZIP/Postal Code
27323240
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08008919295
Email
brasil@bitrialsupport.com
Facility Name
Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP
City
Sao Paulo
ZIP/Postal Code
5403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08008919295
Email
brasil@bitrialsupport.com
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18336022346
Email
canada@bitrialsupport.com
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18336022346
Email
canada@bitrialsupport.com
Facility Name
Teaching Hospital Motol, Oncology Clinic
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800142046
Email
cesko@bitrialsupport.com
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800918118
Email
suomi@bitrialsupport.com
Facility Name
HOP Intercommunal
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Hamburger Zentrum für Kinder- und Jugendrheumatologie
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
General Hospital of Thessaloniki "Ippokrateio"
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008000000092
Email
hellas@bitrialsupport.com
Facility Name
Azienda Ospedaliera Meyer
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
Osp. Pediatrico Bambin Gesù
City
Roma
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
Clinical Research Institute S.C.
City
Tlalnepantla
ZIP/Postal Code
54055
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Amsterdam UMC, Locatie AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08000204613
Email
nederland@bitrialsupport.com
Facility Name
Oslo Universitetssykehus HF, Rikshospitalet
City
Oslo
ZIP/Postal Code
N-0372
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
80058261
Email
norge@bitrialsupport.com
Facility Name
Independent Public Teaching Children's Hospital
City
Warsaw
ZIP/Postal Code
02091
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
CHULC, EPE - Hospital Dona Estefânia
City
Lisboa
ZIP/Postal Code
1169-045
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800856070
Email
portugal@bitrialsupport.com
Facility Name
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800856070
Email
portugal@bitrialsupport.com
Facility Name
CHUP, EPE - Centro Materno Infantil do Norte
City
Porto
ZIP/Postal Code
4050-651
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800856070
Email
portugal@bitrialsupport.com
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
IPD Sharing Time Frame
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
https://www.mystudywindow.com
Description
Related Info

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A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)

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