NINTEDANIB ( DrugBank: Nintedanib )


5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
51全身性強皮症35
85特発性間質性肺炎71
89リンパ脈管筋腫症2
227オスラー病2
228閉塞性細気管支炎3

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04325217
(ClinicalTrials.gov)
April 15, 202026/3/2020Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in JapanPost-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in JapanLung Diseases, InterstitialDrug: NintedanibBoehringer IngelheimNULLRecruitingN/AN/AAll550Japan
2NCT03675581
(ClinicalTrials.gov)
November 8, 201817/9/2018A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)A Phase I Trial to Investigate the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Female Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)Scleroderma, SystemicDrug: Microgynon;Drug: NintedanibBoehringer IngelheimNULLCompleted18 YearsN/AFemale17Phase 1Belgium;France;Germany;Netherlands;Portugal;Spain
3EUCTR2016-003403-66-SE
(EUCTR)
15/10/201814/05/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim ABNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
4EUCTR2016-003403-66-IT
(EUCTR)
28/09/201814/06/2021A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS(TM)- ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: [BIBF 1120]
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: [BIBF 1120]
INN or Proposed INN: NINTEDANIB
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden
5EUCTR2016-003403-66-GR
(EUCTR)
21/09/201814/05/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim B.VNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden
6EUCTR2016-003403-66-FI
(EUCTR)
17/07/201829/06/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R) -ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Fnland KyNULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Malaysia;Thailand;Portugal;Greece;Austria;Netherlands;Sweden;China;Ireland;Brazil;Poland;Chile;France;Argentina;Hungary;Japan;United Kingdom;Switzerland;India;Spain;Canada;Czech Republic;Belgium;Norway;Finland;Denmark;Italy;Mexico;Israel;Australia;Germany
7EUCTR2016-003403-66-CZ
(EUCTR)
20/06/201812/04/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden
8EUCTR2016-003403-66-AT
(EUCTR)
17/04/201828/02/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
9EUCTR2016-003403-66-BE
(EUCTR)
12/04/201812/02/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM) Extension Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
SCS Boehringer Ingelheim Comm. VNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
10EUCTR2016-003403-66-DK
(EUCTR)
05/04/201802/02/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R)-on Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer-Ingelheim Pharma GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden
11EUCTR2016-003403-66-FR
(EUCTR)
04/04/201801/02/2018A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer-Ingelheim FranceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
12EUCTR2016-003403-66-PT
(EUCTR)
23/02/201813/12/2017A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Unilfarma - União Internacional de Lab. Farmacêuticos, Lda.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Norway;Japan;Sweden;United States;Portugal;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany
13EUCTR2016-003403-66-GB
(EUCTR)
07/02/201809/01/2018A trial to evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden
14EUCTR2016-003403-66-ES
(EUCTR)
19/01/201822/11/2017A trial to evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer-Ingelheim España, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
15NCT03313180
(ClinicalTrials.gov)
November 27, 201713/10/2017A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung FibrosisAn Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)Lung Diseases, InterstitialDrug: NintedanibBoehringer IngelheimNULLCompleted18 YearsN/AAll444Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;India;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom;Ireland
16EUCTR2016-003403-66-NL
(EUCTR)
06/11/201727/09/2017A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON Systemic Sclerosis associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden
17EUCTR2015-000392-28-CZ
(EUCTR)
27/06/201727/04/2017A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
520Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
18EUCTR2015-000392-28-HU
(EUCTR)
08/06/201726/04/2017A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
19EUCTR2015-000392-28-NO
(EUCTR)
02/06/201715/02/2017A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Norway KSNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Norway;Germany;Japan;Sweden
20EUCTR2015-000392-28-AT
(EUCTR)
12/05/201731/03/2017A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Belgium;Norway;Germany;Japan;Sweden;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia
21EUCTR2015-000392-28-SE
(EUCTR)
08/05/201724/02/2017A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim ABNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden;Switzerland;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel
22EUCTR2015-000392-28-FI
(EUCTR)
21/02/201710/02/2017A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Finland KyNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
23EUCTR2015-000392-28-IE
(EUCTR)
27/06/201613/04/2016A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
24EUCTR2015-000392-28-PL
(EUCTR)
09/03/201621/01/2016A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer-Ingelheim RCV GmbH&Co KGNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden
25EUCTR2015-000392-28-PT
(EUCTR)
08/01/201614/09/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Unilfarma - União Internacional de Lab. Farmacêuticos, LdaNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
26EUCTR2015-000392-28-IT
(EUCTR)
23/12/201508/06/2021A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - SENSCIS¿ Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 21.0;Level: LLT;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;Classification code 10012977;Term: Diffuse systemic sclerosis;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden;Portugal;United States;Greece
27EUCTR2015-000392-28-FR
(EUCTR)
11/12/201514/12/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 18.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden
28EUCTR2015-000392-28-BE
(EUCTR)
08/12/201525/09/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
SCS Boehringer Ingelheim Comm. VNULLNot RecruitingFemale: yes
Male: yes
520Phase 3Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden;United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China
29EUCTR2015-000392-28-ES
(EUCTR)
19/11/201505/10/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden
30EUCTR2015-000392-28-GR
(EUCTR)
18/11/201522/10/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Ellas SANULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden
31NCT02597933
(ClinicalTrials.gov)
November 12, 20158/10/2015A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung FibrosisA Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)Scleroderma, SystemicDrug: Nintedanib;Drug: PlaceboBoehringer IngelheimNULLCompleted18 YearsN/AAll580Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom
32EUCTR2015-000392-28-DE
(EUCTR)
11/11/201525/08/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
33EUCTR2015-000392-28-GB
(EUCTR)
10/11/201501/09/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim LimitedNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
34EUCTR2015-000392-28-NL
(EUCTR)
02/11/201524/08/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden
35EUCTR2015-000392-28-DK
(EUCTR)
22/09/201522/09/2015A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosisA double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD Patients with Systemic Sclerosis and associated Interstitial Lung Disease
MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Nintedanib
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Boehringer-Ingelheim Pharma GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05195918
(ClinicalTrials.gov)
March 1, 20232/12/2021Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF PatientsDose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients With Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions With Standard of Care Drugs, and Biomarkers of Drug EffectIdiopathic Pulmonary FibrosisCombination Product: EGCG 300 mg + Nintedanib;Combination Product: EGCG 300 mg + Pirfenidone;Combination Product: Placebo 2 capsules + Nintedanib or Pirfenidone;Combination Product: EGCG 600 mg + Nintedanib;Combination Product: EGCG 600 mg + Pirfenidone;Combination Product: Placebo 4 capsules + Nintedanib or PirfenidoneHal ChapmanUniversity of Michigan;Cornell University;Massachusetts General Hospital;Temple University;University of WashingtonNot yet recruiting40 Years85 YearsAll50Phase 1United States
2NCT05373914
(ClinicalTrials.gov)
May 31, 202210/5/2022RESPIRARE - Efficacy and Safety of Cudetaxestat in Patients With Idiopathic Pulmonary Fibrosis (IPF)RESPIRARE - A Phase 2, Randomized, Double-blinded, Placebo-controlled, Efficacy and Safety Study of Cudetaxestat (BLD-0409) Assessed Across Three Dose Ranges With or Without Standard of Care (Nintedanib or Pirfenidone) in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Cudetaxestat (BLD-0409);Drug: Control: Matching PlaceboBlade TherapeuticsNULLNot yet recruiting40 Years85 YearsAll200Phase 2NULL
3NCT04888715
(ClinicalTrials.gov)
July 23, 202128/4/2021To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy VolunteersAn Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy VolunteersIdiopathic Pulmonary FibrosisDrug: DWN12088;Drug: Pirfenidone;Drug: NintedanibDaewoong Pharmaceutical Co. LTD.NULLCompleted19 Years55 YearsAll48Phase 1Korea, Republic of
4NCT05383131
(ClinicalTrials.gov)
June 23, 202112/5/2022To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy VolunteersA Single Center, Open Label Study to Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy VolunteersIdiopathic Pulmonary FibrosisDrug: HEC585;Drug: Pirfenidone;Drug: NintedanibSunshine Lake Pharma Co., Ltd.NULLCompleted18 Years45 YearsAll33Phase 1China
5NCT04739150
(ClinicalTrials.gov)
March 29, 20211/2/2021An Expanded Access Program in Belgium to Provide Nintedanib to People With Lung Diseases Called Non-IPF ILDs Who Have no Alternative Treatment OptionsMedical Need Program With Ofev® (Nintedanib) for the Treatment of Adult Patients With Non-IPF (Idiopathic Pulmonary Fibrosis) Chronic Fibrosing Interstitial Lung Diseases (ILDs) With a Progressive Phenotype (PF-ILD's)Lung Diseases, InterstitialDrug: nintedanibBoehringer IngelheimNULLNo longer available18 YearsN/AAllBelgium
6JPRN-jRCT2031210008
27/01/202102/04/2021A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of CareA Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary FibrosisThis clinical Phase 3 study is a randomized, double-blind, parallel-group, placebo-controlled multicenter study designed to evaluate the efficacy and safety of two doses (200 mg q.d. and 600 mg q.d.) of orally administered GLPG1690 in addition to local standard of care for at least 52 weeks in adult subjects with a centrally confirmed diagnosis of IPF. Local standard of care for IPF is defined as receiving either pirfenidone or nintedanib at a stable dose for at least two months before screening, and during screening; or neither pirfenidone or nintedanib (for any reason). A stable dose is defined as the highest dose tolerated by the subject during those two months. A total of approximately 750 subjects with confirmed diagnosis of IPF will be randomized, 250 subjects in each treatment group (GLPG1690 600 mg q.d., GLPG1690200 mg q.d., or matching placebo).Kayamori TakefumiNULLNot Recruiting>= 40age oldNot applicableBoth49Phase 3Japan;USA;Denmark;Peru;Australia;Germany;Taiwan;Belgium;Greece;Brazil;Spain;Chile;United Kingdom;Czech Republic;Turkey
7NCT04525547
(ClinicalTrials.gov)
January 13, 202121/8/2020Safety and Effectiveness of Nintedanib in Korean PatientsA Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Nintedanib 150mg/100mg BID) in Korean PatientsIdiopathic Pulmonary FibrosisDrug: NintedanibBoehringer IngelheimNULLCompletedN/AN/AAll70Korea, Republic of
8NCT04614441
(ClinicalTrials.gov)
December 25, 202029/10/2020NICEFIT-ON: A Study Under Routine Clinical Practice in Taiwan to Observe the Long-term Outcome of People With Certain Types of Lung Disease (PF-ILD, SSc-ILD, IPF) Who Start Treatment With NintedanibNon-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel TherapyIdiopathic Pulmonary FibrosisDrug: OFEV®Boehringer IngelheimNULLActive, not recruiting20 YearsN/AAll214Taiwan
9NCT03939520
(ClinicalTrials.gov)
June 11, 20203/5/2019Management of Progressive Disease in Idiopathic Pulmonary FibrosisPragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized TrialProgressive Idiopathic Pulmonary FibrosisDrug: pirfenidone and nintedanib;Drug: pirfenidone or nintedanibHospices Civils de LyonNULLRecruiting50 YearsN/AAll378Phase 4France
10EUCTR2019-004326-19-FR
(EUCTR)
27/01/202013/11/2019Management of Progressive Disease in Idiopathic Pulmonary Fibrosis Pragmatic management of progressive disease in idiopathic pulmonary fibrosis: a randomized trial - PROGRESSION-IPF Idiopathic pulmonary fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: pirfenidone
INN or Proposed INN: PIRFENIDONE
Trade Name: nintedanib
Other descriptive name: NINTEDANIB
Hospices Civils de LyonNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
378 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
11JPRN-UMIN000039027
2019/12/2627/12/2019Real world multicenter prospective study of combination therapy of anti-fibrotic agents in idiopathic pulmonary fibrosis(J-AVENGERS)Real world multicenter prospective study of combination therapy of anti-fibrotic agents in idiopathic pulmonary fibrosis(J-AVENGERS) - J-AVENGERS idiopathic pulmonary fibrosis48 weeks of observational period, administration of nintedanib, 100mg or 150mg twice a day and pirfenidone, 200mg, 400mg, or 600mg 3 times a dayJapanese Red Cross Medical CanterNULLRecruiting40years-oldNot applicableMale and Female35Not selectedJapan
12JPRN-jRCTs031190119
28/10/201918/10/2019A phase II Study of CBDCA + ETP + Nintedanib for SCLC with IPFA Phase II Study of Carboplatin and Etoposide Plus Nintedanib for Unresectable Limited/Extensive Disease Small Cell Lung Cancer with Idiopathic Pulmonary Fibrosis - TORG1835 / NEXT-SHIP Unresectable limited or extensive disease small cell lung cancer with idiopathic pulmonary fibrosisThe patients receive carboplatin(area under the curve 5 mg/mL, intravenously, day 1), etoposide (<75 years old:100mg/m2:>=75years old:80mg/m2;intravenously,days 1-3), and nintedanib (150mg twice a day, orally). The patients receive combination chemotherapy every3 weeks for 4 cycles until disease progression or unacceptable toxicity occurs. After completion or discontinuation of carboplatin plus etoposide, the patients continue nintedanib until the discontinuation criteria are satisfied.IKEDA SatoshiOGURA Takashi;Thoracic Oncology Research GroupNot Recruiting>= 20age oldNot applicableBoth33Phase 2Japan
13NCT03562416
(ClinicalTrials.gov)
July 5, 20197/5/2018Continuation of Nintedanib After Single Lung Transplantation in IPF SubjectsNintedanib Plus Usual Transplant Care Compared to Usual Transplant Care Alone After Single Lung Transplantation in Patients With Idiopathic Pulmonary Fibrosis: a Pilot Randomized Controlled TrialIdiopathic Pulmonary Fibrosis;Lung Transplant; ComplicationsDrug: Nintedanib;Drug: Placebo Oral TabletTemple UniversityBoehringer IngelheimRecruiting35 Years70 YearsAll20Phase 2United States
14NCT03710824
(ClinicalTrials.gov)
February 28, 201916/10/2018Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With NintedanibInvestigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With NintedanibIdiopathic Pulmonary FibrosisDrug: NintedanibBoehringer IngelheimNULLActive, not recruiting40 YearsN/AAll180Greece
15NCT03958071
(ClinicalTrials.gov)
February 1, 201920/5/2019A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are TakingCharacteristics of IPF Patients Initiating Nintedanib, Pirfenidone or no Antifibrotic Treatment in the USIdiopathic Pulmonary FibrosisDrug: Nintedanib;Drug: Pirfenidone;Other: Untreated CohortBoehringer IngelheimNULLCompleted40 YearsN/AAll13264United States
16NCT03717012
(ClinicalTrials.gov)
November 15, 201819/10/2018Study of Pulmonary Rehabilitation in Patients With Idiopathic Pulmonary Fibrosis (IPF)Study of Pulmonary Rehabilitation In Nintedanib Treated Patients With IPF: Improvements in Activity, Exercise Endurance Time, and QoLIdiopathic Pulmonary FibrosisDrug: Nintedanib;Other: Pulmonary rehabilitation programBoehringer IngelheimNULLTerminated40 YearsN/AAll19Phase 4United States
17NCT03281200
(ClinicalTrials.gov)
October 24, 201711/9/2017Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in SpainA Multicentre, Retrospective Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain.Idiopathic Pulmonary FibrosisDrug: L - Antineoplastic and immunomodulating agents;Drug: L01 - Antineoplastic agents;Drug: L01X - Other antineoplastic agents;Drug: L01XE - Protein kinase inhibitors;Drug: L01XE31 - NintedanibBoehringer IngelheimNULLCompleted18 YearsN/AAll172Spain
18JPRN-UMIN000026376
2017/09/0103/03/2017Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary FibrosisLong-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in Idiopathic Pulmonary Fibrosis - Long-term Effect of Pulmonary Rehabilitation under Nintedanib treatment in IPF Idiopathic pulmonary fibrosis(IPF)Short-term induction pulmonary rehabilitation (2/1w for the first 12w) + Maintenance pulmonary rehabilitation and outpatient visit (1/4w) Total 52w. / No intervention
Nintedanib / both group
Central Japan Lung Study GrouNULLComplete: follow-up complete40years-old80years-oldMale and Female84Phase 4Japan
19EUCTR2015-002619-14-FR
(EUCTR)
21/06/201725/04/2018Efficacy and safety of nintedanib co-administered with sildenafil in IPF patients with advanced lung function impairmentA 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Revatio
Product Name: Revatio 20 mg
Product Code: sildenafil
INN or Proposed INN: SILDENAFIL
Other descriptive name: sildenafil
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;Italy;United Kingdom;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
20JPRN-jRCTs071180049
23/05/201715/03/2019Japanese Intergroup Study of Nintedanib for NSCLC with IPFA randomized phase III study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis - J-SONIC Advanced Non-small cell lung cancer with idiopathic pulmonary fibrosiscarboplatin + nab-paclitaxel
carboplatin + nab-paclitaxel + nintedanib
Okamoto IsamuOtsubo KoheiComplete>= 20age oldNot applicableBoth240Phase 3Japan
21JPRN-UMIN000026799
2017/05/1201/04/2017A randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosisA randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis - Japanese Intergroup Study of Nintedanib for NSCLC with IPF (J-SONIC) Non-small-cell lung cancer with idiopathic pulmonary fibrosisA: 4 cycles of Carboplatin (AUC 6, day 1) plus nab-Paclitaxel (100 mg/m2, day 1, 8, 15) repeated every 3 weeks
B: 4 cycles of Carboplatin (AUC 6, day 1) plus nab-Paclitaxel (100 mg/m2, day 1, 8, 15) in combination with nintedanib (150 mg B.I.D, daily) repeated every 3 weeks followed by single-agent administration of nintedanib (150 mg B.I.D, daily)
Research Institute for Diseases of the Chest, Kyushu UniversityNULLComplete: follow-up continuing20years-oldNot applicableMale and Female240Phase 3Japan
22EUCTR2015-003148-38-PL
(EUCTR)
08/11/201604/10/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of
23EUCTR2015-002619-14-IT
(EUCTR)
01/09/201604/06/2021Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE(TM):A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: Nintedanib
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: Nintedanib
Trade Name: Revatio
Product Name: Revatio 20 mg
Product Code: sildenafil
INN or Proposed INN: SILDENAFIL
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
24EUCTR2015-002619-14-GB
(EUCTR)
01/08/201608/09/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Revatio
Product Name: Revatio 20 mg
Product Code: sildenafil
INN or Proposed INN: SILDENAFIL
Other descriptive name: sildenafil
Boehringer Ingelheim LimitedNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
25EUCTR2015-002619-14-BE
(EUCTR)
25/07/201603/06/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE (TM) : A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE (TM) patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Revatio
Product Name: Revatio 20 mg
Product Code: sildenafil
INN or Proposed INN: SILDENAFIL
Other descriptive name: sildenafil
SCS Boehringer Ingelheim Comm. VNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
26EUCTR2015-002619-14-DE
(EUCTR)
21/07/201604/05/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentINSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Revatio
Product Name: Revatio 20 mg
Product Code: sildenafil
INN or Proposed INN: SILDENAFIL
Other descriptive name: sildenafil
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
27EUCTR2015-003148-38-DE
(EUCTR)
14/07/201620/05/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
490 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
28NCT02802345
(ClinicalTrials.gov)
June 30, 201614/6/2016Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function ImpairmentINSTAGE: A 24-week, Double-blind, Randomized, Parallel-group Study Evaluating the Efficacy and Safety of Oral Nintedanib Co-administered With Oral Sildenafil, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Advanced Lung Function ImpairmentIdiopathic Pulmonary FibrosisDrug: Nintedanib;Drug: Placebo;Drug: SildenafilBoehringer IngelheimNULLCompleted40 YearsN/AAll274Phase 3United States;Australia;Belgium;Canada;France;Germany;India;Italy;Japan;Korea, Republic of;Mexico;Spain;United Kingdom
29EUCTR2015-002619-14-ES
(EUCTR)
29/06/201617/05/2016Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairmentA 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Revatio
Product Name: Revatio 20 mg
Product Code: sildenafil
INN or Proposed INN: SILDENAFIL
Other descriptive name: sildenafil
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of
30EUCTR2015-003148-38-ES
(EUCTR)
13/06/201611/03/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
31NCT02788474
(ClinicalTrials.gov)
June 9, 201627/5/2016Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity ImpairmentA 12-week, Double Blind, Randomised, Placebo Controlled, Parallel Group Trial Followed by a Single Active Arm Phase of 40 Weeks Evaluating the Effect of Oral Nintedanib 150 mg Twice Daily on Change in Biomarkers of Extracellular Matrix (ECM) Turnover in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Limited Forced Vital Capacity (FVC) Impairment.Idiopathic Pulmonary FibrosisDrug: nintedanib;Drug: placeboBoehringer IngelheimNULLCompleted40 YearsN/AAll347Phase 4United States;Australia;Belgium;Czechia;Finland;France;Germany;Hungary;Japan;Korea, Republic of;Poland;Spain;United Kingdom;Czech Republic
32EUCTR2015-003148-38-GB
(EUCTR)
06/06/201618/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim LimitedNULLNot Recruiting Female: yes
Male: yes
490 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
33EUCTR2015-003148-38-BE
(EUCTR)
06/06/201619/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
SCS Boehringer Ingelheim Comm. VNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
34EUCTR2015-003148-38-HU
(EUCTR)
27/05/201612/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
35EUCTR2015-003148-38-CZ
(EUCTR)
26/05/201611/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
490Phase 4Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of;United States
36EUCTR2015-003148-38-FR
(EUCTR)
24/05/201604/05/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
37EUCTR2015-003148-38-FI
(EUCTR)
17/05/201612/04/2016Effect of nintedanib on biomarkersA 12-week, double blind, randomised, placebo controlled, parallel group trial followed by a single active arm phase of 40 weeks evaluating the effect of oral nintedanib 150 mg twice daily on change in biomarkers of extracellular matrix (ECM) turnover in patients with idiopathic pulmonary fibrosis (IPF) and limited forced vital capacity (FVC) impairment.
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Boehringer Ingelheim Finland KyNULLNot RecruitingFemale: yes
Male: yes
490Phase 4United States;Finland;Spain;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
38EUCTR2015-003280-11-NL
(EUCTR)
29/04/201619/01/2016A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Germany;Netherlands;Italy
39NCT02606877
(ClinicalTrials.gov)
April 19, 201616/11/2015A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in CombinationInvestigation of Drug-drug Interaction Between Nintedanib and Pirfenidone in Patients With IPF (an Open Label, Multiple-dose, Two Group Study)Idiopathic Pulmonary FibrosisDrug: nintedanib;Drug: pirfenidoneBoehringer IngelheimNULLCompleted40 YearsN/AAll37Phase 4United Kingdom
40JPRN-UMIN000021591
2016/04/0401/04/2016The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumoniaThe pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia - The pilot study of Nintedanib and Carboplatin plus Paclitaxel for advanced non-small cell lung cancer with idiopathic interstitial pneumonia Advanced non-small cell lung cancer with idiopathic interstitial pneumoniacarboplatin AUC6 D1
paclitaxel 200mg/m D1
tryweekly 4cycle
nintedanib 150mg twice daily
Hirosaki University Graduate School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female30Not selectedJapan
41EUCTR2015-003280-11-DE
(EUCTR)
25/02/201619/10/2015A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
42JPRN-UMIN000020722
2016/01/2625/01/2016Prospective study of efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosisProspective study of efficiency of fibrosis score in computed tomography as predictor after treatment with Nintedanib for idiopathic pulmonary fibrosis - The CT study with Nintedanib idiopathic pulmonary fibrosisadministration of 150mg of nintedanib twice dailyKanagawa Cardiovascular and Respiratory CenterNULLRecruiting40years-oldNot applicableMale and Female30Not applicableJapan
43JPRN-UMIN000020682
2016/01/2222/01/2016The comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosisThe comparison of the efficacy and safety of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis - The comparison of antifibrotic agents in patients with idiopathic pulmonary fibrosis Idiopathic pulmonary fibrosispirfenidone 12 months 200-600mg t.i.d or b.i.d
nintedanib 12 months 100-150mg b.i.d
National Hospital Organization Ibarakihigashi National HospitalThe center of Chest Diseases and Severe Motor&Intellectual DisabilitiesNULLPending20years-oldNot applicableMale and Female60Not applicableJapan
44EUCTR2015-003280-11-DK
(EUCTR)
20/01/201625/11/2015A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
45NCT02598193
(ClinicalTrials.gov)
January 14, 20164/11/2015Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)An Exploratory Multicenter, Open-Label, Single Arm Study of the Safety and Tolerability of Pirfenidone (Esbriet®) in Combination With Nintedanib (Ofev®) in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Nintedanib;Drug: PirfenidoneHoffmann-La RocheNULLCompleted40 Years80 YearsAll89Phase 4United States;Canada;Denmark;France;Germany;Italy;Netherlands;Spain
46EUCTR2015-000640-42-IT
(EUCTR)
22/12/201522/02/2018Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib incombination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - - Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
INN or Proposed INN: nintedanib
Other descriptive name: nintedanib
Trade Name: Ofev
INN or Proposed INN: Nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Esbriet
INN or Proposed INN: PIRFENIDONE
Other descriptive name: PIRFENIDONE
BOEHRINGER-INGELHEIM ITALIA S.P.A.NULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Netherlands;Germany;Italy
47EUCTR2015-003280-11-IT
(EUCTR)
17/12/201527/05/2021A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET¿) IN COMBINATION WITH NINTEDANIB (OFEV¿) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS - NA Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: ESBRIET - 267 MG - CAPSULA RIGIDA - USO ORALE - FLACONE (HDPE) 270 CAPSULE
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
INN or Proposed INN: NINTEDANIB
F. HOFFMANN - LA ROCHE LTD.NULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
48EUCTR2015-003280-11-ES
(EUCTR)
16/12/201530/10/2015A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary FibrosisAN EXPLORATORY MULTICENTER, OPEN-LABEL, SINGLE ARM STUDY OF THE SAFETY AND TOLERABILITY OF PIRFENIDONE (ESBRIET®) IN COMBINATION WITH NINTEDANIB (OFEV®) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS Idiopathic Pulmonary Fibrosis (IPF)
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Esbriet
Product Name: Esbriet
Product Code: RO0220912
INN or Proposed INN: PIRFENIDONE
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev
Product Code: 534-1508
INN or Proposed INN: NINTEDANIB
Roche Farma S.A., que representa en España a F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
80Phase 4France;United States;Canada;Spain;Denmark;Netherlands;Germany;Italy
49EUCTR2015-000640-42-DE
(EUCTR)
01/12/201503/09/2015Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib iin combination with pirfenidone in IPF Idiopathic Pulmonary Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Esbriet
Product Name: pirfenidone
Product Code: pirfenidone
INN or Proposed INN: PIRFENIDONE
Other descriptive name: PIRFENIDONE
Boehringer Ingelheim Pharma GmbH & Co.KGNULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Netherlands;Germany;Italy
50NCT02579603
(ClinicalTrials.gov)
October 16, 201516/10/2015Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPFA Twelve Week, Open-label, Randomised, Parallel-group Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Oral Nintedanib in Combination With Oral Pirfenidone, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF)Idiopathic Pulmonary FibrosisDrug: Nintedanib;Drug: PirfenidoneBoehringer IngelheimNULLCompleted40 YearsN/AAll105Phase 4United States;Canada;France;Germany;Italy;Netherlands
51JPRN-UMIN000019436
2015/10/1621/10/2015Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidoneRandomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone - Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone idiopathic pulmonary fibrosisNintedanib+pirfenidone group;
Nintedanib 150mg twice daily
Pirfenidone 600-1800mg/day
Nintedanib group;
Nintedanib 150mg twice daily
Kanagawa Cardiovascular and Respiratory CenterNULLComplete: follow-up complete40years-oldNot applicableMale and Female60Phase 2Japan
52EUCTR2015-000640-42-NL
(EUCTR)
13/10/201518/08/2015Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib iin combination with pirfenidone in IPF Idiopathic Pulmonary Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Esbriet
Product Name: pirfenidone
Product Code: pirfenidone
INN or Proposed INN: PIRFENIDONE
Other descriptive name: PIRFENIDONE
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
135Phase 4France;United States;Canada;Germany;Netherlands;Italy
53NCT02607722
(ClinicalTrials.gov)
August 31, 20152/9/2015All-Case Surveillance of Ofev in Patients With IPF in JapanThe Special Drug Use-results Survey (All-Case Surveillance) of Ofev® Capsules in Patients With Idiopathic Pulmonary Fibrosis (IPF) in JapanIdiopathic Pulmonary FibrosisDrug: NintedanibBoehringer IngelheimNULLRecruitingN/AN/AAll6000Japan
54EUCTR2015-000640-42-FR
(EUCTR)
26/08/201505/08/2015Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPFA twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) - Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF Idiopathic Pulmonary Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ofev
Product Name: Ofev 100 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Ofev
Product Name: Ofev 150 mg capsule
Product Code: nintedanib
INN or Proposed INN: nintedanib
Other descriptive name: NINTEDANIB
Trade Name: Esbriet
Product Name: pirfenidone
Product Code: pirfenidone
INN or Proposed INN: PIRFENIDONE
Other descriptive name: PIRFENIDONE
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
135Phase 4United States;France;Canada;Netherlands;Germany;Italy
55NCT02230982
(ClinicalTrials.gov)
November 12, 201429/8/2014Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary FibrosisMulti-center Open-label Expanded Access Program of Oral Nintedanib 150 mg Twice Daily in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: nintedanibBoehringer IngelheimNULLNo longer available40 YearsN/AAllBrazil
56NCT02171156
(ClinicalTrials.gov)
May 201418/6/2014Expanded Access Program of Nintedanib in Patients With Idiopathic Pulmonary Fibrosis (EAP)Multi-center Open-label Expanded Access Program of Oral Nintedanib 150 mg Twice Daily in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: nintedanibBoehringer IngelheimNULLApproved for marketing40 YearsN/AAllN/AUnited States
57NCT01979952
(ClinicalTrials.gov)
November 26, 20134/11/2013Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)A Six Month Double Blind Randomized Placebo Controlled Trial Followed by Each Arm Being Converted to Oral Nintedanib 150 mg Twice Daily Comparing the Effect on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George's Respiratory Questionnaire After Six Months of Treatment in Patients With Idiopathic Pulmonary Fibrosis With Continued Evaluations Over a Period of up to Eighteen MonthsIdiopathic Pulmonary FibrosisDrug: Matching Placebo;Drug: NintedanibBoehringer IngelheimNULLCompleted40 YearsN/AAll113Phase 3United States;Canada;Turkey
58NCT01890265
(ClinicalTrials.gov)
July 30, 201324/6/2013Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary FibrosisDrug: Pamrevlumab;Drug: Placebo;Drug: Sub-Study: Pirfenidone;Drug: Sub-Study: NintedanibFibroGenNULLCompleted40 Years80 YearsAll160Phase 2United States;Australia;Bulgaria;Canada;India;New Zealand;South Africa
59EUCTR2011-002766-21-IE
(EUCTR)
23/04/201315/02/2013Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
60EUCTR2011-002766-21-CZ
(EUCTR)
03/08/201219/06/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
61EUCTR2011-002766-21-IT
(EUCTR)
25/07/201219/06/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Greece;Finland;Spain;Ireland;Turkey;Russian Federation;Chile;Israel;United Kingdom;Italy;India;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Germany;China;Japan;Korea, Republic of
62EUCTR2011-002766-21-DE
(EUCTR)
02/07/201204/05/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
63EUCTR2011-002766-21-BE
(EUCTR)
26/06/201226/04/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
SCS Boehringer Ingelheim Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
64EUCTR2011-002766-21-ES
(EUCTR)
18/06/201226/04/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim España S.ANULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Russian Federation;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
65EUCTR2011-002766-21-GB
(EUCTR)
15/06/201221/05/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) - Idiopathic Pulmonary Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
66EUCTR2011-002766-21-FI
(EUCTR)
06/06/201216/05/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Israel;Russian Federation;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
67EUCTR2011-002766-21-GR
(EUCTR)
02/05/201211/04/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim HellasNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Chile;Russian Federation;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
68EUCTR2011-002766-21-PT
(EUCTR)
20/04/201220/04/2012Long term safety study of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Unilfarma - União Internacional de Lab. Farmacêuticos, LdaNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan
69NCT01417156
(ClinicalTrials.gov)
September 201115/8/2011Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)A Phase II Open Label, Follow up Study to Investigate the Long Term Tolerability and Safety of Oral BIBF 1120 on Top of Pirfenidone in Japanese Patients With Idiopathic Pulmonary FibrosisPulmonary FibrosisDrug: Nintedanib;Drug: PirfenidoneoneBoehringer IngelheimNULLCompleted40 YearsN/AAll20Phase 2Japan
70EUCTR2009-013788-21-CZ
(EUCTR)
02/08/201028/07/2010study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary FibrosisA phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: nintedanib
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;Greece;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Bulgaria;Germany
71EUCTR2009-013788-21-HU
(EUCTR)
16/06/201005/07/2010A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary FibrosisA phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: Not applicable
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: Not applicable
Product Name: BIBF 1120
Product Code: BIBF 1120
INN or Proposed INN: Nintedanib
Other descriptive name: Not applicable
Boehringer Ingelheim RCV GmBH & Co KGNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Portugal;France;Czech Republic;Hungary;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;United Kingdom;Italy

89. リンパ脈管筋腫症


臨床試験数 : 38 薬物数 : 38 - (DrugBank : 15) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 118
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03062943
(ClinicalTrials.gov)
December 6, 20167/10/2016A Study of Nintedanib for LymphAngioleioMyomatosis (LAM)A Pilot Study of Nintedanib for LymphAngioleioMyomatosis (LAM)LymphangioleiomyomatosisDrug: NintedanibIRCCS MultimedicaNULLCompleted18 YearsN/AFemale30Phase 2Italy
2EUCTR2015-004919-20-IT
(EUCTR)
09/03/201611/08/2016A pilot study of nintedanib for lymphangioleiomyomatosis (LAM)A pilot study of nintedanib for lymphangioleiomyomatosis (LAM) - A pilot study of nintedanib for lymphangioleiomyomatosis (LAM) Female subjects affected by Llymphangioleiomyomatosis (LAM)
MedDRA version: 19.0;Level: PT;Classification code 10049459;Term: Lymphangioleiomyomatosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: OfevMULTIMEDICA S.P.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
30Phase 3Italy

227. オスラー病


臨床試験数 : 56 薬物数 : 72 - (DrugBank : 21) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 136
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03954782
(ClinicalTrials.gov)
June 22, 202015/5/2019Efficacy of Nintedanib Per os as a Treatment for Epistaxis in HHT Disease.Efficacy of Nintedanib Per os as a Treatment for Epistaxis in HHT Disease. A National, Randomized, Multicentre Phase II StudyTelangiectasia, Hereditary Hemorrhagic;Rendu Osler DiseaseDrug: Nintedanib 150 mg and 100 mg soft capsules;Drug: Oral treatment of placebo soft capsuleHospices Civils de LyonNULLRecruiting18 YearsN/AAll60Phase 2France
2EUCTR2019-002593-31-FR
(EUCTR)
05/11/201905/09/2019Efficacy of Nintedanib per os as a treatment for epistaxis in HHT diseaseEPICUREEfficacy of Nintedanib per os as a treatment for epistaxis in HHT diseaseA national, randomized, multicenter phase II studyEPICURE Hereditary Hemorrhagic Telangiectasia
MedDRA version: 20.1;Level: LLT;Classification code 10019887;Term: Hereditary hemorrhagic telangiectasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: OFEV
Product Name: nintédanib
Other descriptive name: NINTEDANIB
Hospices Civils de LyonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2France

228. 閉塞性細気管支炎


臨床試験数 : 97 薬物数 : 118 - (DrugBank : 32) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 156
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03283007
(ClinicalTrials.gov)
October 30, 20196/9/2017Nintedanib in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome Grade 0p-1-2A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) Recipients With Bronchiolitis Obliterans Syndrome (BOS) Grade 0p-1-2Lung-transplant RecipientsDrug: Nintedanib;Drug: PlaceboAssistance Publique - Hôpitaux de ParisNULLRecruiting18 YearsN/AAll80Phase 3France
2EUCTR2018-001747-31-FR
(EUCTR)
09/04/201928/12/2018 A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) recipients with bronchiolitis obliterans syndrome (BOS) grade 1-2 A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Tranplant (LTx) recipients with bronchiolitis obliterans sydrome (BOS) grade 1-2 - INFINITX BOS Bronchiolitis Obliterating Syndrome (SBO) grade 1 or 2 in patients with pulmonary transplantation.
MedDRA version: 20.0;Level: PT;Classification code 10029888;Term: Obliterative bronchiolitis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: OFEV
INN or Proposed INN: Nintedanib
Other descriptive name: Nintedanib
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
80 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
3NCT03805477
(ClinicalTrials.gov)
March 20, 20198/1/2019Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell TransplantationNintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation (HSCT)- a Multicentre Phase II TrialBronchiolitis Obliterans Syndrome (BOS);Bronchiolitis Obliterans (BO)Drug: NintedanibUniversity Hospital, Basel, SwitzerlandNULLRecruiting18 YearsN/AAll20Phase 2Switzerland;Austria;Germany