ITF2357 ( DrugBank: - )

4 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
96	クローン病	5
107	若年性特発性関節炎	7
113	筋ジストロフィー	18
267	高ＩｇＤ症候群	1

96. クローン病

臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215

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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	EUCTR2007-000189-19-IT (EUCTR)	10/06/2008	17/10/2008	Multicenter, randomized, double-blind, placebo-controlled, study to evaluate the effect of ITF2357on ...	Multicenter, randomized, double-blind, placebo-controlled, study to evaluate the effect of ITF2357on ...	Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease	Product Name: ITF 2357	ITALFARMACO	NULL	Not Recruiting			Female: yes Male: yes	80		Netherlands;Belgium;Italy
2	NCT00792740 (ClinicalTrials.gov)	October 2007	14/11/2008	Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357on ...	Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357on ...	Crohn's Disease	Drug: ITF2357;Drug: Placebo capsules	Italfarmaco	NULL	Terminated	18 Years	88 Years	Both	51	Phase 1/Phase 2	Belgium
3	EUCTR2007-000189-19-BE (EUCTR)	16/08/2007	03/08/2007	Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357on ...	Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357on ...	Moderate-to-severe active Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 1001140 ...	Product Code: ITF2357	Italfarmaco S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	80		Netherlands;Belgium;Italy
4	EUCTR2007-000189-19-NL (EUCTR)	06/08/2007	14/06/2007	Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357on ...	Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357on ...	Moderate-to-severe active Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 1001140 ...	Product Code: ITF2357	Italfarmaco S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	80		Netherlands;Belgium;Italy
5	EUCTR2004-004854-19-SK (EUCTR)	25/04/2005	09/02/2005	A randomized, double-blind, placebo-controlled, parallel group multicenter study to investigate effi ...	A randomized, double-blind, placebo-controlled, parallel group multicenter study to investigate effi ...	Crohn's disease	Product Name: ITF2357 Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl ...	Italfarmaco S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 2	Slovakia

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107. 若年性特発性関節炎

臨床試験数 : 441 / 薬物数 : 282 - (DrugBank : 56) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 142

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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	EUCTR2011-003341-18-CZ (EUCTR)	14/10/2011	05/09/2011	NAP	An Open-Label Extension of the Dose Finding study (DSC/08/2357/36) in patients with polyarticular co ...	Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 14.1;Level: PT;Classif ...	Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydr ...	Italfarmaco S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	3		Czech Republic
2	EUCTR2010-019094-15-BE (EUCTR)	07/12/2010	20/05/2010	A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administ ...	A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administ ...	Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classi ...	Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydr ...	Italfarmaco S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 2	Czech Republic;Slovenia;Spain;Belgium;Italy
3	EUCTR2010-019094-15-ES (EUCTR)	06/09/2010	26/05/2010	Estudio multicéntrico y abierto, de búsqueda de dosis para evaluar eficacia y seguridad de Givinosta ...	Estudio multicéntrico y abierto, de búsqueda de dosis para evaluar eficacia y seguridad de Givinosta ...	Artritis Idiopática Juvenil de evolución poliarticular (AIJ poli) / Polyarticular course Juvenile Id ...	Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydr ...	Italfarmaco S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	20		Czech Republic;Slovenia;Spain;Italy
4	EUCTR2010-019094-15-SI (EUCTR)	17/08/2010	22/06/2010	A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administ ...	A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administ ...	Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classi ...	Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydr ...	Italfarmaco S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	20		Czech Republic;Slovenia;Spain;Italy
5	EUCTR2010-019094-15-CZ (EUCTR)	01/07/2010	17/05/2010	A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administ ...	A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administ ...	Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classi ...	Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydr ...	Italfarmaco S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	20		Czech Republic;Slovenia;Spain;Italy
6	EUCTR2006-000089-35-IT (EUCTR)	17/08/2006	30/08/2006	Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy o ...	Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy o ...	systemic onset juvenile idiopathic arthritis Level: PTClassification code 10059177	Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 Product Code: IT ...	ITALFARMACO	NULL	Not Recruiting			Female: yes Male: yes	16	Phase 2	Italy
7	NCT00570661 (ClinicalTrials.gov)	August 2006	10/12/2007	Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy o ...	Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy o ...	Active Systemic;Onset Juvenile Idiopathic Arthritis	Drug: ITF2357	Italfarmaco	NULL	Completed	2 Years	25 Years	Both	17	Phase 2	Serbia;Former Serbia and Montenegro

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113. 筋ジストロフィー

臨床試験数 : 622 / 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168

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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	NCT04821063 (ClinicalTrials.gov)	April 13, 2021	26/3/2021	Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 ...	A Randomized, Partially Double-Blind, Four-Period, Four-Treatment, Crossover Study Investigating the ...	Duchenne and Becker Muscular Dystrophy;Polycytemia Vera	Drug: ITF2357 10 mg/mL;Drug: Placebo;Drug: Moxifloxacin Hydrochloride	Italfarmaco	NULL	Completed	18 Years	55 Years	All	31	Phase 1	Canada
2	EUCTR2017-000397-10-GB (EUCTR)	20/01/2020	15/03/2019	Study in which all the patients take the same investigational drug with theaim of evaluate the long- ...	Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who ...	Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: ...	Product Name: GIVINOSTAT (hyrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinos ...	ITALFARMACO S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	185	Phase 3	France;United States;Canada;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom
3	EUCTR2017-000397-10-NL (EUCTR)	01/10/2019	06/11/2019	Study in which all the patients take the same investigational drug with the aim of evaluate the long ...	Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who ...	Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givino ...	ITALFARMACO S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	222	Phase 3	France;United States;Serbia;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy
4	EUCTR2017-000397-10-BE (EUCTR)	12/06/2019	12/02/2019	Study in which all the patients take the same investigational drug with the aim of evaluate the long ...	Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who ...	Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givino ...	ITALFARMACO S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	185	Phase 3	United States;France;Canada;Spain;Belgium;Netherlands;Germany;United Kingdom;Italy
5	EUCTR2017-000397-10-ES (EUCTR)	16/05/2019	11/04/2019	Study in which all the patients take the same investigational drug with the aim of evaluate the long ...	Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who ...	Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givino ...	ITALFARMACO S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	185	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	France;United States;Canada;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom
6	EUCTR2017-001629-41-NL (EUCTR)	15/11/2018	31/05/2018	Study to evaluate the micro-macroscopic effects on muscles, the safety and tolerability, and the eff ...	A randomised, double-blind, placebo-controlled study to evaluate the micro-macroscopic effects on mu ...	Distrofia Muscolare di Becker (DMB) MedDRA version: 20.0;Level: PT;Classification code 10059117;Term ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givino ...	ITALFARMACO S.P.A.	NULL	Not Recruiting			Female: no Male: yes	48	Phase 2	Netherlands;Italy
7	EUCTR2017-001629-41-IT (EUCTR)	08/09/2017	15/01/2021	Study to evaluate the micro-macroscopic effects on muscles, the safety and tolerability, and the eff ...	A randomised, double-blind, placebo-controlled study to evaluate the micro-macroscopic effects on mu ...	Becker Muscular Dystrophy (BMD) MedDRA version: 20.0;Level: PT;Classification code 10059117;Term: Be ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givino ...	ITALFARMACO S.P.A.	NULL	Not Recruiting			Female: no Male: yes	55	Phase 2	Netherlands;Italy
8	EUCTR2017-000397-10-IT (EUCTR)	31/07/2017	30/01/2018	Studio nel quale tutti i pazienti prendono lo stesso farmaco sperimentale con lo scopo di valutare a ...	Studio in aperto a lungo termine volto a valutare la sicurezza, la tollerabilità e l'efficacia di GI ...	Distrofia Muscolare di Duchenne (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Te ...	Product Name: Givinostat (idrocloruro monoidrato) Product Code: ITF2357 INN or Proposed INN: Givinosta ...	ITALFARMACO S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	France;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom;Italy
9	EUCTR2016-000401-36-NL (EUCTR)	28/06/2017	14/12/2016	Study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular ...	Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety ...	Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givino ...	ITALFARMACO S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	169	Phase 3	France;United States;Serbia;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy
10	EUCTR2016-000401-36-IT (EUCTR)	24/05/2017	08/02/2017	Study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular ...	Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety ...	Duchenne Muscular Dystrophy (DMD) MedDRA version: 19.1;Level: PT;Classification code 10013801;Term: ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givino ...	ITALFARMACO S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	192	Phase 3	France;United States;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy

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267. 高ＩｇＤ症候群

臨床試験数 : 11 / 薬物数 : 6 - (DrugBank : 1) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 44

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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	NCT00442182 (ClinicalTrials.gov)	September 2006	28/2/2007	The Efficacy and Safety of ITF2357 in AIS	The Effects and Side Effects of ITS2357 in Autoinflammatory Syndromes	Autoinflammatory Syndromes;HIDS;TRAPS;Schnitzler's Syndrome	Drug: ITF2357	Radboud University	NULL	Recruiting	18 Years	N/A	Both	20	Phase 2	Netherlands

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