Progressive Fibrosing Interstitial Lung Disease (PF-ILD) MedDRA version: 20.0 Level: LLT Classification code 10066393 Term: Respiratory bronchiolitis-associated interstitial lung disease System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Ofev
Product Name: Nintedanib 150mg capsules
Product Code: Nintedanib
Pharmaceutical Form: Capsule, soft
INN or Proposed INN
Sponsors
Boehringer Ingelheim España, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 completed (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247);Secondary Objective: Not applicable;Primary end point(s): 1. The primary endpoint is the incidence of overall adverse events over the course of this extension trial.;Timepoint(s) of evaluation of this end point: 1. End of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. No secondary efficacy endpoints are defined.;Timepoint(s) of evaluation of this end point: 1. No secondary efficacy endpoints are defined. | — |
Countries
Argentina, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed