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［全身型若年性特発性関節炎（~2018.3）］ | 2 |
| 113 | 筋ジストロフィー | 11 |
| 267 | 高IgD症候群 | 1 |
| 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 ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn?s Disease - DSC/06/2357/23 | Multicenter, randomized, double-blind, placebo-controlled, study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn?s Disease - DSC/06/2357/23 | 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 ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease | 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 ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease | Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease | Moderate-to-severe active Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | 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 ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease | Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease | Moderate-to-severe active Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | 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 efficacy and safety of ITF 2357 in the management of patients with active moderate to severe Crohn’s disease | A randomized, double-blind, placebo-controlled, parallel group multicenter study to investigate efficacy and safety of ITF 2357 in the management of patients with active moderate to severe Crohn’s disease | Crohn's disease | Product Name: ITF2357 Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphtalen-2-ylmethyl]-ammonium chloride mon | Italfarmaco S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Slovakia |
| 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 | EUCTR2006-000089-35-IT (EUCTR) | 17/08/2006 | 30/08/2006 | Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - ND | Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - ND | systemic onset juvenile idiopathic arthritis Level: PTClassification code 10059177 | Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 Product Code: ITF2357 | ITALFARMACO | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | Italy | ||
| 2 | NCT00570661 (ClinicalTrials.gov) | August 2006 | 10/12/2007 | Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy of Oral ITF2357 in Patients With Active Systemic Onset Juvenile Idiopathic Arthritis (SOJIA) | Phase II, Open Label, International, Multicentre Clinical Trial to Investigate Safety and Efficacy of Oral ITF2357 in Patients With Active Systemic Onset Juvenile Idiopathic Arthritis (SOJIA) | Active Systemic;Onset Juvenile Idiopathic Arthritis | Drug: ITF2357 | Italfarmaco | NULL | Completed | 2 Years | 25 Years | Both | 17 | Phase 2 | Serbia;Former Serbia and Montenegro |
| 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 | 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-term safety, tolerability, and efficacy ofGIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophywho have been already treated in one of the GIVINOSTAT studies in thepast | Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies. - Givinostat DMD long term study | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GIVINOSTAT (hyrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | 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 | ||
| 2 | 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-term safety, tolerability, and efficacy of GIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophy who have been already treated in one of the GIVINOSTAT studies in the past | Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies - Givinostat DMD long term study | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | 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;Germany;Netherlands;United Kingdom;Italy | ||
| 3 | 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-term safety, tolerability, and efficacy of GIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophy who have been already treated in one of the GIVINOSTAT studies in the past | Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies - Givinostat DMD long term study | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | 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 | ||
| 4 | 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 efficacy of givinostat in patients with Becker Muscular Dystrophy | A randomised, double-blind, placebo-controlled study to evaluate the micro-macroscopic effects on muscles, the safety and tolerability, and the efficacy ofgivinostat in patients with Becker Muscular Dystrophy - NA | Distrofia Muscolare di Becker (DMB) MedDRA version: 20.0;Level: PT;Classification code 10059117;Term: Becker's muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 48 | Phase 2 | Netherlands | ||
| 5 | 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 Dystrophy. | Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. | Duchenne Muscular Dystrophy (DMD) MedDRA version: 19.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | 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 | ||
| 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 |
| 6 | EUCTR2016-000401-36-GB (EUCTR) | 07/03/2017 | 26/10/2016 | Study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. | Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. - EPIDYS | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 169 | Phase 3 | United States;Serbia;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2016-000401-36-ES (EUCTR) | 10/02/2017 | 10/02/2017 | Study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. | Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. | Duchenne Muscular Dystrophy (DMD) MedDRA version: 19.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 192 | Phase 3 | France;United States;Canada;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 8 | EUCTR2012-002566-12-IT (EUCTR) | 04/02/2013 | 17/10/2012 | A Two-Part Study to Assess the Safety and Tolerability, Pharmacokinetics, and Effects on Histology and Different Clinical Parameters of Givinostat in Ambulant Children with Duchenne Muscular Dystrophy | A Two-Part Study to Assess the Safety and Tolerability, Pharmacokinetics, and Effects on Histology and Different Clinical Parameters of Givinostat in Ambulant Children with Duchenne Muscular Dystrophy - DSC | Duchenne Muscular Dystrophy MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat Other descriptive name: givinostat Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat Other descriptive name: Givinostat | ITALFARMACO | NULL | Not Recruiting | Female: no Male: yes | 20 | Phase 2 | Italy | ||
| 9 | EUCTR2016-000401-36-FR (EUCTR) | 16/05/2017 | Study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. | Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | NA | Female: no Male: yes | 192 | Phase 3 | United States;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | |||
| 10 | EUCTR2017-000397-10-DE (EUCTR) | 22/01/2019 | Study in which all the patients take the same investigational drug with the aim of evaluate the long-term safety, tolerability, and efficacy of GIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophy who have been already treated in one of the GIVINOSTAT studies in the past | Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies - Givinostat DMD long term study | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 185 | Phase 3 | United States;Serbia;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy | |||
| 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 |
| 11 | EUCTR2017-000397-10-FR (EUCTR) | 09/09/2019 | Study in which all the patients take the same investigational drug with the aim of evaluate the long-term safety, tolerability, and efficacy of GIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophy who have been already treated in one of the GIVINOSTAT studies in the past | Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies - Givinostat DMD long term study | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | NA | Female: no Male: yes | 185 | Phase 3 | United States;France;Canada;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom |
| 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 |