A follow-up study investigating long term treatment with nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Phase 1

• Conditions: Progressive Fibrosing Interstitial Lung Disease (PF-ILD); MedDRA version: 21.1Level: LLTClassification code 10066393Term: Respiratory bronchiolitis-associated interstitial lung diseaseSystem Organ Class: 100000004855; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2018-000525-32-BE
• Lead Sponsor: SCS Boehringer Ingelheim Comm.V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-30
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified