An open-label extension trial of the long term safety of nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) - Nintedanib in PF-ILD (extension)

Boehringer Ingelheim Pharma GmbH & Co. KG0 个研究点目标入组 480 人开始时间: 2019年1月17日最近更新: 2021年11月15日

研究概览

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•1. Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
•2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
•3. Women of childbearing potential (WOCBP) 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 335
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 145

•1. 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.
•2. 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
•3. Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator’s judgement.
•4. Previous enrolment in this trial.
•5. Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes the patient an unreliable trial participant or unlikely to complete the trial.
•6. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.

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