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A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

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ClinicalTrials.gov Identifier: NCT03820726
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).

Condition or disease Intervention/treatment Phase
Lung Diseases, Interstitial Drug: Nintedanib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All subjects Drug: Nintedanib
Bid




Primary Outcome Measures :
  1. Incidence of overall adverse events over the course of this extension trial [ Time Frame: Up to 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  • Women of childbearing potential (WOCBP)1 must continue to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information

Exclusion Criteria:

  • Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator's benefit-risk assessment remains favourable.
  • 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 trial
  • Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.
  • Previous enrolment in this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820726


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03820726     History of Changes
Other Study ID Numbers: 1199-0248
2018-000525-32 ( EudraCT Number )
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

  1. Studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action