A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
NCT03820726 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 435
Last updated 2023-09-13
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).
Conditions
- Lung Diseases, Interstitial
Interventions
- DRUG
-
Bid
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-16
- Primary Completion
- 2022-08-30
- Completion
- 2022-08-30
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Belgium
- Canada
- Chile
- China
- France
- Germany
- Italy
- Japan
- Poland
- Russia
- South Korea
- Spain
- United Kingdom
Study Locations
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