A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03820726
Collaborator
(none)
436
121
1
40.5
3.6
0.1
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
436 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Actual Study Start Date
:
Apr 16, 2019
Anticipated Primary Completion Date
:
Aug 31, 2022
Anticipated Study Completion Date
:
Aug 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: All subjects
|
Drug: Nintedanib
Bid
|
Outcome Measures
Primary Outcome Measures
- Incidence of overall adverse events over the course of this extension trial [Up to 36 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts 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. Further exclusion criteria apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | University of California Los Angeles | Los Angeles | California | United States | 90095 |
| 3 | University of California Davis | Sacramento | California | United States | 95817 |
| 4 | National Jewish Health | Denver | Colorado | United States | 80206 |
| 5 | Yale University School of Medicine | New Haven | Connecticut | United States | 06510 |
| 6 | Pulmonary and Sleep of Tampa Bay | Brandon | Florida | United States | 33511 |
| 7 | University of Florida College of Medicine | Jacksonville | Florida | United States | 32209 |
| 8 | Emory University | Atlanta | Georgia | United States | 30322 |
| 9 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 10 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 11 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 12 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21224 |
| 13 | Pulmonary and Critical Care Associates of Baltimore | Towson | Maryland | United States | 21286 |
| 14 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 15 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 16 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 17 | Mayo Clinic, Rochester | Rochester | Minnesota | United States | 55905 |
| 18 | The Lung Research Center, LLC | Chesterfield | Missouri | United States | 63017 |
| 19 | Creighton University | Omaha | Nebraska | United States | 68124 |
| 20 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 21 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
| 22 | Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | United States | 10032 |
| 23 | NewYork-Presbyterian/Weill Cornell Medical Center | New York | New York | United States | 10065 |
| 24 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 25 | The Oregon Clinic | Portland | Oregon | United States | 97220 |
| 26 | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 27 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 28 | Baylor University Medical Center | Dallas | Texas | United States | 75246 |
| 29 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 30 | Diagnostics Research Group | San Antonio | Texas | United States | 78229 |
| 31 | Medical Arts and Research Center (MARC) | San Antonio | Texas | United States | 78229 |
| 32 | University of Utah Health Sciences Center | Salt Lake City | Utah | United States | 84108 |
| 33 | Inova Fairfax Medical Campus | Falls Church | Virginia | United States | 22042 |
| 34 | Centro Dr. Lazaro Langer S.R.L | Alberdi Sur | Argentina | X5003DCE | |
| 35 | Centro de Investigaciones Metabólicas (CINME) | C.a.b.a | Argentina | 1056 | |
| 36 | CEMER-Centro Medico De Enfermedades Respiratorias | Florida | Argentina | B1602DQD | |
| 37 | INSARES | Mendoza | Argentina | M5500CCG | |
| 38 | Instituto Médico de la Fundación Estudios Clínicos | Rosario | Argentina | S2000DEJ | |
| 39 | ULB Hopital Erasme | Bruxelles | Belgium | 1070 | |
| 40 | UZ Leuven | Leuven | Belgium | 3000 | |
| 41 | Centre Hospitalier Universitaire de Liège | Liège | Belgium | 4000 | |
| 42 | Yvoir - UNIV UCL de Mont-Godinne | Yvoir | Belgium | 5530 | |
| 43 | Winnipeg Clinic | Winnipeg | Manitoba | Canada | R3C 0N2 |
| 44 | St. Joseph's Healthcare Hamilton | Hamilton | Ontario | Canada | L8N 4A6 |
| 45 | Toronto General Hospital | Toronto | Ontario | Canada | M5G 2N2 |
| 46 | CHUS Fleurimont | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 47 | Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente" | Concepción | Chile | 4070038 | |
| 48 | Instituto Nacional del Tórax | Providencia, Santiago De Chile | Chile | 7500691 | |
| 49 | Centro de Investigación del Maule | Talca | Chile | 3465586 | |
| 50 | Peking Union Medical College Hospital | Beijing | China | 100730 | |
| 51 | Nanjing Drum Tower Hospital | Nanjing | China | 210008 | |
| 52 | The First Hospital of Chinese Medical University | Shenyang | China | 110001 | |
| 53 | HOP Avicenne | Bobigny | France | 93009 | |
| 54 | HOP Louis Pradel | Bron | France | 69677 | |
| 55 | HOP Côte de Nacre | Caen | France | 14033 | |
| 56 | CHRU Lille | Lille | France | 59037 | |
| 57 | HOP Nord | Marseille | France | 13915 | |
| 58 | HOP Arnaud de Villeneuve | Montpellier | France | 34295 | |
| 59 | HOP Pasteur | Nice | France | 06001 | |
| 60 | HOP Bichat | Paris | France | 75018 | |
| 61 | HOP Maison Blanche | Reims | France | 51092 | |
| 62 | HOP Pontchaillou | Rennes | France | 35033 | |
| 63 | HOP Civil | Strasbourg | France | 67091 | |
| 64 | HOP Bretonneau | Tours | France | 37044 | |
| 65 | Universitätsklinikum Bonn AöR | Bonn | Germany | 53105 | |
| 66 | Fachkrankenhaus Coswig GmbH | Coswig | Germany | 01640 | |
| 67 | Klinik Donaustauf | Donaustauf | Germany | 93093 | |
| 68 | Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH | Essen | Germany | 45239 | |
| 69 | Medizinische Hochschule Hannover | Hannover | Germany | 30625 | |
| 70 | Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg | Heidelberg | Germany | 69126 | |
| 71 | Petrus-Krankenhaus | Wuppertal | Germany | 42283 | |
| 72 | A.O.U. Policlinico Vittorio Emanuele | Catania | Italy | 95124 | |
| 73 | Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli | Forli' | Italy | 47121 | |
| 74 | Azienda Ospedaliera Policlinico di Modena | Modena | Italy | 41100 | |
| 75 | A.O. San Gerardo di Monza | Monza | Italy | 20052 | |
| 76 | Poli Univ A. Gemelli | Roma | Italy | 00168 | |
| 77 | A.O.U. Senese Policlinico Santa Maria alle Scotte | Siena | Italy | 53100 | |
| 78 | Tosei General Hospital | Aichi, Seto | Japan | 489-8642 | |
| 79 | Kurume University Hospital | Fukuoka, Kurume | Japan | 830-0011 | |
| 80 | Sapporo Medical University Hospital | Hokkaido, Sapporo | Japan | 060-8543 | |
| 81 | National Hospital Organization Himeji Medical Center | Hyogo, Himeji | Japan | 670-8520 | |
| 82 | Kobe City Medical Center General Hospital | Hyogo, Kobe | Japan | 650-0047 | |
| 83 | Ibarakihigashi National Hospial | Ibaraki, Naka-gun | Japan | 319-1113 | |
| 84 | Kanagawa Cardiovascular and Respiratory Center | Kanagawa, Yokohama | Japan | 236-0051 | |
| 85 | Saiseikai Kumamoto Hospital | Kumamoto, Kumamoto | Japan | 861-4193 | |
| 86 | Tohoku University Hospital | Miyagi, Sendai | Japan | 980-8574 | |
| 87 | National Hospital Organization Kinki-Chuo Chest Medical Center | Osaka, Sakai | Japan | 591-8555 | |
| 88 | Osaka Medical College Hospital | Osaka, Takatsuki | Japan | 569-8686 | |
| 89 | Hamamatsu University Hospital | Shizuoka, Hamamatsu | Japan | 431-3192 | |
| 90 | Tokushima University Hospital | Tokushima, Tokushima | Japan | 770-8503 | |
| 91 | Tokyo Medical and Dental University Hospital | Tokyo, Bunkyo-ku | Japan | 113-8519 | |
| 92 | Toranomon Hospital | Tokyo, Minato-ku | Japan | 105-8470 | |
| 93 | JR Tokyo General Hospital | Tokyo, Shibuya-ku | Japan | 151-8528 | |
| 94 | Center Hospital of the National Center for Global Health and Medicine | Tokyo, Shinjuku-ku | Japan | 162-8655 | |
| 95 | The Catholic University of Korea, Bucheon St.Mary's Hospital | Bucheon | Korea, Republic of | 14647 | |
| 96 | Seoul National University Bundang Hospital | Seongnam | Korea, Republic of | 13620 | |
| 97 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 98 | University Clinical Center, Gdansk | Gdansk | Poland | 80-214 | |
| 99 | Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ. | Katowice | Poland | 40-752 | |
| 100 | Norbert Barlicki University Clinical Hospital No.1, Lodz | Lodz | Poland | 90-153 | |
| 101 | Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa | Warszawa | Poland | 01-138 | |
| 102 | Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA | Zabrze | Poland | 41-803 | |
| 103 | Res.Inst.-Compl.Iss.Cardi.Dis. | Kemerovo | Russian Federation | 650002 | |
| 104 | Central Scientific Research Insitute of Tuberculosis | Moscow | Russian Federation | 107564 | |
| 105 | Moscow 1st State Med.Univ.n.a.I.M.Sechenov | Moscow | Russian Federation | 119992 | |
| 106 | 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst. | St. Petersburg | Russian Federation | 197022 | |
| 107 | Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl | Yaroslavl | Russian Federation | 150003 | |
| 108 | Hospital Santa Creu i Sant Pau | Barcelona | Spain | 08026 | |
| 109 | Hospital de Galdakao | Galdakao | Spain | 48960 | |
| 110 | Hospital de Bellvitge | L'Hospitalet de Llobregat | Spain | 08907 | |
| 111 | Hospital La Princesa | Madrid | Spain | 28006 | |
| 112 | Hospital Central de Asturias | Oviedo | Spain | 33011 | |
| 113 | Hospital Son Espases | Palma de Mallorca | Spain | 07120 | |
| 114 | Hospital de Canarias | San Cristóbal de La Laguna | Spain | 38320 | |
| 115 | Hospital Virgen del Rocío | Sevilla | Spain | 41013 | |
| 116 | Royal Infirmary of Edinburgh | Edinburgh | United Kingdom | EH16 4SA | |
| 117 | St James's University Hospital | Leeds | United Kingdom | LS9 7TF | |
| 118 | Royal Brompton Hospital | London | United Kingdom | SW3 6NP | |
| 119 | Wythenshawe Hospital | Manchester | United Kingdom | M23 9LT | |
| 120 | University Hospital Llandough | Penarth | United Kingdom | CF64 2XX | |
| 121 | Royal Stoke University Hospital | Stoke-on-Trent | United Kingdom | ST4 6QG |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03820726
Other Study ID Numbers:
- 1199-0248
- 2018-000525-32
First Posted:
Jan 29, 2019
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: