Lung Diseases, Interstitial (in Pediatric Populations)NCT05624281
A Treatment Protocol to Support the Care of Children and Adolescents With Fibrosing Interstitial Lung Disease (ILD)
A study testing nintedanib in people with Lung Diseases, Interstitial (in Pediatric Populations) and Childhood Interstitial Lung Disease (chILD), run by Boehringer Ingelheim.
Trial summary
This Expanded Access Program (EAP) is intended to facilitate the availability of OFEV® (nintedanib) to children and adolescents with chronic fibrosing interstitial lung disease (ILD) on top of current standard of care treatment and for whom no satisfactory authorized alternative therapy exists and who cannot… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Lung Diseases, Interstitial (in Pediatric Populations), Childhood Interstitial Lung Disease (chILD)
- What is being tested?
- nintedanib
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who are not eligible or unable to participate in the ongoing 1199-0378 trial.
- Children and adolescents 6 to 17 years old at Visit 1.
- Signed and dated written informed consent and assent, where applicable, in accordance with International Council on Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Male or female patients. Females 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 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 and in the protocol.
- Patients with evidence of fibrosing Interstitial Lung Disease (ILD) on high-resolution computed tomography (HRCT) within 12 months of Visit 1 as assessed and documented by the investigator.
- Further inclusion criteria for the determination of fibrosing ILD on HRCT are defined in the protocol.
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- Patients with Forced Vital Capacity (FVC) % predicted ≥25% at Visit 1.
- Patients with clinically significant disease at Visit 1, as assessed by the investigator:
- Fan score >3
- 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).
Who cannot join
- Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the program.
- Currently enrolled in another investigational device or drug program, or less than 30 days since ending another investigational device or drug program(s) or receiving other investigational treatment(s). This does not apply to nintedanib.
- Women who are pregnant, nursing, or who plan to become pregnant while in the program.
- Aspartate Transaminase (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.
- Estimated Glomerular Filtration Rate (eGFR) <30 mL/min calculated by Schwartz formula at Visit 1.
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- 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 greater but ≥1 week) prior to Visit 1.
- Further exclusion criteria apply.
About this study
Official title: Expanded Access Program of OFEV® (Nintedanib) in Children and Adolescents (6- to 17-year-old) With Clinically Significant Fibrosing Interstitial Lung Disease (ILD)
This Expanded Access Program (EAP) is intended to facilitate the availability of OFEV® (nintedanib) to children and adolescents with chronic fibrosing interstitial lung disease (ILD) on top of current standard of care treatment and for whom no satisfactory authorized alternative therapy exists and who cannot participate in the ongoing 1199-0378 trial.
- Conditions
- Lung Diseases, Interstitial (in Pediatric Populations), Childhood Interstitial Lung Disease (chILD)
- Being tested
- nintedanib
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nintedanibDrug
Also called OFEV®
nintedanib, for patients with fibrosing interstitial lung disease (ILD); in this EAP limited to children and adolescents
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, Interstitial (in Pediatric Populations)Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624281
- Sponsor's protocol ID
- 1199-0511
- Status last verified
- Jan 2024
- First submitted
- 4 Nov 2022
- Last updated
- 12 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program of OFEV® (Nintedanib) in Children and Adolescents (6- to 17-year-old) With Clinically Significant Fibrosing Interstitial Lung Disease (ILD)
- ClinicalTrials.gov ID
- NCT05624281
- Acronym / sponsor ID
- 1199-0511
- Conditions
- Lung Diseases, Interstitial (in Pediatric Populations), Childhood Interstitial Lung Disease (chILD)
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Expanded Access Program (EAP) is intended to facilitate the availability of OFEV® (nintedanib) to children and adolescents with chronic fibrosing interstitial lung disease (ILD) on top of current standard of care treatment and for whom no satisfactory authorized alternative therapy exists and who cannot participate in the ongoing 1199-0378 trial.
Study design
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Patients who are not eligible or unable to participate in the ongoing 1199-0378 trial.
- Children and adolescents 6 to 17 years old at Visit 1.
- Signed and dated written informed consent and assent, where applicable, in accordance with International Council on Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Male or female patients. Females 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 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 and in the protocol.
- Patients with evidence of fibrosing Interstitial Lung Disease (ILD) on high-resolution computed tomography (HRCT) within 12 months of Visit 1 as assessed and documented by the investigator.
Key exclusion criteria (9 listed)
- Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the program.
- Currently enrolled in another investigational device or drug program, or less than 30 days since ending another investigational device or drug program(s) or receiving other investigational treatment(s). This does not apply to nintedanib.
- Women who are pregnant, nursing, or who plan to become pregnant while in the program.
- Aspartate Transaminase (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nintedanibAlso: OFEV®nintedanib, for patients with fibrosing interstitial lung disease (ILD); in this EAP limited to children and adolescents | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing nintedanib in people with Lung Diseases, Interstitial (in Pediatric Populations) and Childhood Interstitial Lung Disease (chILD), run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.