A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

  • Interventional
  • Not Recruiting
  • NCT03820726
Eligibility Details Visit Clinicaltrials.gov

An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

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).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.
  • Lung Disease

At a Glance

National Government IDNCT03820726

IRB#IRB19-0077

Lead SponsorBoehringer Ingelheim

Lead PhysicianMary Elizabeth Strek

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting