Status:
COMPLETED
A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Lung Diseases, Interstitial
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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. Further exclusion criteria apply.
Key Trial Info
Start Date :
April 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
435 Patients enrolled
Trial Details
Trial ID
NCT03820726
Start Date
April 16 2019
End Date
August 30 2022
Last Update
September 13 2023
Active Locations (121)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of California Los Angeles
Los Angeles, California, United States, 90095
3
University of California Davis
Sacramento, California, United States, 95817
4
National Jewish Health
Denver, Colorado, United States, 80206