A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive … (NCT03820726) | Clinical Trial Compass
CompletedPhase 3
A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
United States435 participantsStarted 2019-04-16
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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. Further exclusion criteria apply.
What they're measuring
1
Number of Participants With Any Adverse Events
Timeframe: From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.