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

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04325217 (ClinicalTrials.gov)	April 15, 2020	26/3/2020	Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Int ...	Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Int ...	Lung Diseases, Interstitial	Drug: Nintedanib	Boehringer Ingelheim	NULL	Recruiting	N/A	N/A	All	550		Japan
2	NCT03675581 (ClinicalTrials.gov)	November 8, 2018	17/9/2018	A Study to Test Whether NintedanibInfluences the Components of Birth-control Pills in Women With Sys ...	A Phase I Trial to Investigate the Effect of Nintedanibon the Pharmacokinetics of a Combination of E ...	Scleroderma, Systemic	Drug: Microgynon;Drug: Nintedanib	Boehringer Ingelheim	NULL	Completed	18 Years	N/A	Female	17	Phase 1	Belgium;France;Germany;Netherlands;Portugal;Spain
3	EUCTR2016-003403-66-SE (EUCTR)	15/10/2018	14/05/2018	A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma re ...	An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic ...	Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classificati ...	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other ...	Boehringer Ingelheim AB	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Mal ...
4	EUCTR2016-003403-66-IT (EUCTR)	28/09/2018	14/06/2021	A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma re ...	An open-label extension trial to assess the long term safety of nintedanibin patients with ‘Systemic ...	Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classificati ...	Trade Name: Ofev Product Name: Nintedanib Product Code: [BIBF 1120] INN or Proposed INN: NINTEDANIB Trad ...	BOEHRINGER-INGELHEIM ITALIA S.P.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Mal ...
5	EUCTR2016-003403-66-GR (EUCTR)	21/09/2018	14/05/2018	A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma re ...	An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic ...	Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classificati ...	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other ...	Boehringer Ingelheim B.V	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Mal ...
6	EUCTR2016-003403-66-FI (EUCTR)	17/07/2018	29/06/2018	A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma re ...	An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic ...	Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classificati ...	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other ...	Boehringer Ingelheim Fnland Ky	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	United States;Malaysia;Thailand;Portugal;Greece;Austria;Netherlands;Sweden;China;Ireland;Brazil;Pola ...
7	EUCTR2016-003403-66-CZ (EUCTR)	20/06/2018	12/04/2018	A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma re ...	An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic ...	Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classificati ...	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other ...	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Mal ...
8	EUCTR2016-003403-66-AT (EUCTR)	17/04/2018	28/02/2018	A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma re ...	An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic ...	Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classificati ...	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other ...	Boehringer Ingelheim RCV GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Mal ...
9	EUCTR2016-003403-66-BE (EUCTR)	12/04/2018	12/02/2018	A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma re ...	An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic ...	Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classificati ...	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other ...	SCS Boehringer Ingelheim Comm. V	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Mal ...
10	EUCTR2016-003403-66-DK (EUCTR)	05/04/2018	02/02/2018	A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma re ...	An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic ...	Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classificati ...	Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other ...	Boehringer-Ingelheim Pharma GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Mal ...

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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

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT05195918 (ClinicalTrials.gov)	March 1, 2023	2/12/2021	Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients	Dose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients Wi ...	Idiopathic Pulmonary Fibrosis	Combination Product: EGCG 300 mg + Nintedanib;Combination Product: EGCG 300 mg + Pirfenidone;Combina ...	Hal Chapman	University of Michigan;Cornell University;Massachusetts General Hospital;Temple University;Universit ...	Not yet recruiting	40 Years	85 Years	All	50	Phase 1	United States
2	NCT05373914 (ClinicalTrials.gov)	May 31, 2022	10/5/2022	RESPIRARE - 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 ...	Idiopathic Pulmonary Fibrosis	Drug: Cudetaxestat (BLD-0409);Drug: Control: Matching Placebo	Blade Therapeutics	NULL	Not yet recruiting	40 Years	85 Years	All	200	Phase 2	NULL
3	NCT04888715 (ClinicalTrials.gov)	July 23, 2021	28/4/2021	To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanibin Healthy Voluntee ...	An Open Label, 2-part, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between DWN12 ...	Idiopathic Pulmonary Fibrosis	Drug: DWN12088;Drug: Pirfenidone;Drug: Nintedanib	Daewoong Pharmaceutical Co. LTD.	NULL	Completed	19 Years	55 Years	All	48	Phase 1	Korea, Republic of
4	NCT05383131 (ClinicalTrials.gov)	June 23, 2021	12/5/2022	To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanibin Healthy Volunteers ...	A Single Center, Open Label Study to Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone ...	Idiopathic Pulmonary Fibrosis	Drug: HEC585;Drug: Pirfenidone;Drug: Nintedanib	Sunshine Lake Pharma Co., Ltd.	NULL	Completed	18 Years	45 Years	All	33	Phase 1	China
5	NCT04739150 (ClinicalTrials.gov)	March 29, 2021	1/2/2021	An Expanded Access Program in Belgium to Provide Nintedanibto People With Lung Diseases Called Non-I ...	Medical Need Program With Ofev® (Nintedanib) for the Treatment of Adult Patients With Non-IPF (Idiop ...	Lung Diseases, Interstitial	Drug: nintedanib	Boehringer Ingelheim	NULL	No longer available	18 Years	N/A	All			Belgium
6	JPRN-jRCT2031210008	27/01/2021	02/04/2021	A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary F ...	A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evalu ...	Idiopathic Pulmonary Fibrosis	This clinical Phase 3 study is a randomized, double-blind, parallel-group, placebo-controlled multic ...	Kayamori Takefumi	NULL	Not Recruiting	>= 40age old	Not applicable	Both	49	Phase 3	Japan;USA;Denmark;Peru;Australia;Germany;Taiwan;Belgium;Greece;Brazil;Spain;Chile;United Kingdom;Cze ...
7	NCT04525547 (ClinicalTrials.gov)	January 13, 2021	21/8/2020	Safety and Effectiveness of Nintedanib in Korean Patients	A Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Ninte ...	Idiopathic Pulmonary Fibrosis	Drug: Nintedanib	Boehringer Ingelheim	NULL	Completed	N/A	N/A	All	70		Korea, Republic of
8	NCT04614441 (ClinicalTrials.gov)	December 25, 2020	29/10/2020	NICEFIT-ON: A Study Under Routine Clinical Practice in Taiwan to Observe the Long-term Outcome of Pe ...	Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel Therapy	Idiopathic Pulmonary Fibrosis	Drug: OFEV®	Boehringer Ingelheim	NULL	Active, not recruiting	20 Years	N/A	All	214		Taiwan
9	NCT03939520 (ClinicalTrials.gov)	June 11, 2020	3/5/2019	Management of Progressive Disease in Idiopathic Pulmonary Fibrosis	Pragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized Trial	Progressive Idiopathic Pulmonary Fibrosis	Drug: pirfenidone and nintedanib;Drug: pirfenidone or nintedanib	Hospices Civils de Lyon	NULL	Recruiting	50 Years	N/A	All	378	Phase 4	France
10	EUCTR2019-004326-19-FR (EUCTR)	27/01/2020	13/11/2019	Management of Progressive Disease in Idiopathic Pulmonary Fibrosis	Pragmatic management of progressive disease in idiopathic pulmonary fibrosis: a randomized trial - P ...	Idiopathic pulmonary fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idio ...	Trade Name: pirfenidone INN or Proposed INN: PIRFENIDONE Trade Name: nintedanib Other descriptive name: ...	Hospices Civils de Lyon	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	378	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	France

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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

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03062943 (ClinicalTrials.gov)	December 6, 2016	7/10/2016	A Study of Nintedanib for LymphAngioleioMyomatosis (LAM)	A Pilot Study of Nintedanib for LymphAngioleioMyomatosis (LAM)	Lymphangioleiomyomatosis	Drug: Nintedanib	IRCCS Multimedica	NULL	Completed	18 Years	N/A	Female	30	Phase 2	Italy
2	EUCTR2015-004919-20-IT (EUCTR)	09/03/2016	11/08/2016	A pilot study of nintedanib for lymphangioleiomyomatosis (LAM)	A pilot study of nintedanibfor lymphangioleiomyomatosis (LAM) - A pilot study of nintedanibfor lymph ...	Female subjects affected by Llymphangioleiomyomatosis (LAM) MedDRA version: 19.0;Level: PT;Classific ...	Trade Name: Ofev	MULTIMEDICA S.P.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: no	30	Phase 3	Italy

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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

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03954782 (ClinicalTrials.gov)	June 22, 2020	15/5/2019	Efficacy of Nintedanib Per os as a Treatment for Epistaxis in HHT Disease.	Efficacy of NintedanibPer os as a Treatment for Epistaxis in HHT Disease. A National, Randomized, Mu ...	Telangiectasia, Hereditary Hemorrhagic;Rendu Osler Disease	Drug: Nintedanib 150 mg and 100 mg soft capsules;Drug: Oral treatment of placebo soft capsule	Hospices Civils de Lyon	NULL	Recruiting	18 Years	N/A	All	60	Phase 2	France
2	EUCTR2019-002593-31-FR (EUCTR)	05/11/2019	05/09/2019	Efficacy of Nintedanib per os as a treatment for epistaxis in HHT diseaseEPICURE	Efficacy of Nintedanibper os as a treatment for epistaxis in HHT diseaseA national, randomized, mult ...	Hereditary Hemorrhagic Telangiectasia MedDRA version: 20.1;Level: LLT;Classification code 10019887;T ...	Trade Name: OFEV Product Name: nintédanib Other descriptive name: NINTEDANIB	Hospices Civils de Lyon	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	France

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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

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03283007 (ClinicalTrials.gov)	October 30, 2019	6/9/2017	Nintedanib in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome Grade 0p-1-2	A Multi-center, Randomised, Double-blind Trial of Nintedanibin Lung Transplant (LTx) Recipients With ...	Lung-transplant Recipients	Drug: Nintedanib;Drug: Placebo	Assistance Publique - Hôpitaux de Paris	NULL	Recruiting	18 Years	N/A	All	80	Phase 3	France
2	EUCTR2018-001747-31-FR (EUCTR)	09/04/2019	28/12/2018	A Multi-center, Randomised, Double-blind Trial of Nintedanibin Lung Transplant (LTx) recipients with ...	A Multi-center, Randomised, Double-blind Trial of Nintedanibin Lung Tranplant (LTx) recipients with ...	Bronchiolitis Obliterating Syndrome (SBO) grade 1 or 2 in patients with pulmonary transplantation. M ...	Trade Name: OFEV INN or Proposed INN: Nintedanib Other descriptive name: Nintedanib	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	France
3	NCT03805477 (ClinicalTrials.gov)	March 20, 2019	8/1/2019	Nintedanibin Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Trans ...	Nintedanibin Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Trans ...	Bronchiolitis Obliterans Syndrome (BOS);Bronchiolitis Obliterans (BO)	Drug: Nintedanib	University Hospital, Basel, Switzerland	NULL	Recruiting	18 Years	N/A	All	20	Phase 2	Switzerland;Austria;Germany

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