A Phase 3 interventional study of Nintedanib in Idiopathic Pulmonary Fibrosis, sponsored by Boehringer Ingelheim. Completed at 173 sites in 24 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-03-25.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.
680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.
This study's enrollment of 752 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
patient to receive a capsule containing Nintedanib twice a day
Drug: Nintedanib
Nintedanib twice a day
Also known as: BIBF 1120
Incidence of Adverse Events (AEs)
This is the measure for percentage of patients with adverse events (AEs) observed during the trial. The incidence of adverse events (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.
Time frame: From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.
This was a prospective, open-label extension trial in which patients with Idiopathic pulmonary fibrosis (IPF), who had completed 52 weeks of treatment and the follow-up period in the randomised, double-blind, placebo-controlled parent trials 1199.32(NCT01335464)/.34(NCT01335477) and who needed access to nintedanib outside of the discontinued parent trials 1199.35(NCT01170065)/.187(NCT01979952).
| Milestone | Total (1199.32/.34/.35/.187) |
|---|---|
| Started | 752 |
| Treated | 751 |
| Completed | 227 |
| Not completed | 525 |
| Withdrew: Adverse event | 231 |
| Withdrew: Protocol violation | 4 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Withdrawal by subject | 45 |
| Withdrew: Other than specified | 96 |
| Withdrew: Not treated | 1 |
| Withdrew: Death | 145 |
This is the measure for percentage of patients with adverse events (AEs) observed during the trial. The incidence of adverse events (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.
| Percentage of patients (%) | Total (1199.32/.34) |
|---|---|
| Any AEs | 98.5 |
| AEs leading to discontinuation of trial drug | 42.6 |
| Serious AEs | 68.9 |
| Fatal AEs | 23.8 |
Collected over From first drug administration in this study until 28 days after the last drug, up to 7.5 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total (1199.32/.34) | 182/734 (24.8%) | 509/734 (69.3%) | 671/734 (91.4%) |
| Placebo (1199.32/.34) | 78/304 (25.7%) | 208/304 (68.4%) | 281/304 (92.4%) |
| Nintedanib 150 Bid (1199.32/.34) | 104/430 (24.2%) | 301/430 (70%) | 390/430 (90.7%) |
| Placebo (1199.187) | 0/7 (0%) | 0/7 (0%) | 3/7 (42.9%) |
| Nintedanib 100 Bid (1199.35) | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Nintedanib 150 Bid (1199.35/.187) | 0/8 (0%) | 1/8 (12.5%) | 2/8 (25%) |
| Total (1199.35/.187) | 0/17 (0%) | 1/17 (5.9%) | 6/17 (35.3%) |
| Total (1199.32/.34/.35/.187) | 182/751 (24.2%) | 510/751 (67.9%) | 677/751 (90.1%) |
| Event | Total (1199.32/.34) | Placebo (1199.32/.34) | Nintedanib 150 Bid (1199.32/.34) | Placebo (1199.187) | Nintedanib 100 Bid (1199.35) | Nintedanib 150 Bid (1199.35/.187) | Total (1199.35/.187) | Total (1199.32/.34/.35/.187) |
|---|---|---|---|---|---|---|---|---|
| Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders | 153/734 | 64/304 | 89/430 | 0/7 | 0/2 | 0/8 | 0/17 | 153/751 |
| PneumoniaInfections and infestations | 99/734 | 40/304 | 59/430 | 0/7 | 0/2 | 0/8 | 0/17 | 99/751 |
| CholelithiasisHepatobiliary disorders | 9/734 | 4/304 | 5/430 | 0/7 | 0/2 | 1/8 | 1/17 | 10/751 |
| Pulmonary hypertensionRespiratory, thoracic and mediastinal disorders | 48/734 | 22/304 | 26/430 | 0/7 | 0/2 | 0/8 | 0/17 | 48/751 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 35/734 | 9/304 | 26/430 | 0/7 | 0/2 | 0/8 | 0/17 | 35/751 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 38/734 | 16/304 | 22/430 | 0/7 | 0/2 | 0/8 | 0/17 | 38/751 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 17/734 | 11/304 | 6/430 | 0/7 | 0/2 | 0/8 | 0/17 | 17/751 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 13/734 | 9/304 | 4/430 | 0/7 | 0/2 | 0/8 | 0/17 | 13/751 |
| Respiratory tract infectionInfections and infestations | 13/734 | 8/304 | 5/430 | 0/7 | 0/2 | 0/8 | 0/17 | 13/751 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 15/734 | 4/304 | 11/430 | 0/7 | 0/2 | 0/8 | 0/17 | 15/751 |
| Event | Total (1199.32/.34) | Placebo (1199.32/.34) | Nintedanib 150 Bid (1199.32/.34) | Placebo (1199.187) | Nintedanib 100 Bid (1199.35) | Nintedanib 150 Bid (1199.35/.187) | Total (1199.35/.187) | Total (1199.32/.34/.35/.187) |
|---|---|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 514/734 | 213/304 | 301/430 | 2/7 | 0/2 | 0/8 | 2/17 | 516/751 |
| InfluenzaInfections and infestations | 35/734 | 11/304 | 24/430 | 0/7 | 1/2 | 0/8 | 1/17 | 36/751 |
| CoughRespiratory, thoracic and mediastinal disorders | 166/734 | 66/304 | 100/430 | 0/7 | 0/2 | 0/8 | 0/17 | 166/751 |
| NauseaGastrointestinal disorders | 146/734 | 70/304 | 76/430 | 0/7 | 0/2 | 0/8 | 0/17 | 146/751 |
| BronchitisInfections and infestations | 145/734 | 54/304 | 91/430 | 0/7 | 0/2 | 0/8 | 0/17 | 145/751 |
| NasopharyngitisInfections and infestations | 152/734 | 62/304 | 90/430 | 0/7 | 0/2 | 0/8 | 0/17 | 152/751 |
| Weight decreasedInvestigations | 123/734 | 63/304 | 60/430 | 0/7 | 0/2 | 0/8 | 0/17 | 123/751 |
| Decreased appetiteMetabolism and nutrition disorders | 104/734 | 58/304 | 46/430 | 0/7 | 0/2 | 0/8 | 0/17 | 104/751 |
| Upper respiratory tract infectionInfections and infestations | 109/734 | 38/304 | 71/430 | 0/7 | 0/2 | 0/8 | 0/17 | 109/751 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 118/734 | 48/304 | 70/430 | 0/7 | 0/2 | 1/8 | 1/17 | 119/751 |
Treated set (TS): The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose, and had participated in 1199.32/.34 parent trials.
| Age, Continuous(Years) | Total (1199.32/.34) |
|---|---|
| Mean | 67.2 ± 7.8 |
| Sex: Female, Male(Participants) | Total (1199.32/.34) |
|---|---|
| Female | 147 |
| Male | 587 |
| Race (NIH/OMB)(Participants) | Total (1199.32/.34) |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 214 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 431 |
| More than one race | 0 |
| Unknown or Not Reported | 86 |
Showing the first 100 of 173 sites across 24 countries.
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Boehringer Ingelheim