ITF2357 ( DrugBank: - )
4 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 96 | Crohn disease | 5 |
| 107 | Juvenile idiopathic arthritis | 7 |
| 113 | Muscular dystrophy | 18 |
| 267 | Hyper-IgD syndrome | 1 |
96. Crohn disease
Clinical trials : 2,442 / Drugs : 1,278 - (DrugBank : 248) / Drug target genes : 142 - Drug target pathways : 209
| 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 |
107. Juvenile idiopathic arthritis
Clinical trials : 447 / Drugs : 297 - (DrugBank : 57) / Drug target genes : 52 - Drug target pathways : 146
| 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 course Juvenile Idiopathic Arthritis (poly JIA) - - | Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;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 (hydrochloride-monohydrate) Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl- phenyl carbamoyloxymethyl)-naphthalen-2-yl methyl]-ammonium chloride; monohydrate | 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 administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) | 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 Givinostat administrado en dos dosis diferentes en pacientes que cursan artritis idiopática juvenil de evolución poliarticular (AIJ poli) que no están respondiendo adecuadamente al tratamiento estándar / A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Estudio multicéntrico y abierto, de búsqueda de dosis para evaluar eficacia y seguridad de Givinostat administrado en dos dosis diferentes en pacientes que cursan artritis idiopática juvenil de evolución poliarticular (AIJ poli) que no están respondiendo adecuadamente al tratamiento estándar / A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Artritis Idiopática Juvenil de evolución poliarticular (AIJ poli) / Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) | 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 administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) | 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 administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment | Polyarticular course Juvenile Idiopathic Arthritis (poly JIA) MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride-monohydrate) | 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 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 | ||
| 7 | 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 |
113. Muscular dystrophy
Clinical trials : 646 / Drugs : 471 - (DrugBank : 105) / Drug target genes : 59 - Drug target pathways : 170
| 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 (Givinostat) and Moxifloxacin on QT/QTC Interval | A Randomized, Partially Double-Blind, Four-Period, Four-Treatment, Crossover Study Investigating the Placebo-Corrected Effects of a Therapeutic Dose (100 mg) and a Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval in Healthy Male and Female Subjects | 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-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 | Canada;Netherlands;Belgium;United States;United Kingdom;Italy;Germany;Spain;France | ||
| 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-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 | 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-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 | ||
| 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-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 study long term | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | 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 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 | 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 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 of givinostat in patients with Becker Muscular Dystrophy - NA | Becker Muscular Dystrophy (BMD) 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 | 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 lungo termine la sicurezza, la tollerabilità e l'efficacia del GIVINOSTAT in pazienti affetti da distrofia muscolare di Duchenne che sono stati precedentemente trattati in uno studio con GIVINOSTAT. | Studio in aperto a lungo termine volto a valutare la sicurezza, la tollerabilità e l'efficacia di GIVINOSTAT in pazienti affetti da distrofia muscolare di Duchenne che sono stati precedentemente trattati in studio con GIVINOSTAT. - Studio con Givinostat in DMD a lungo termine | Distrofia Muscolare di Duchenne (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 (idrocloruro monoidrato) Product Code: ITF2357 INN or Proposed INN: Givinostat (idrocloruro monoidrato) Other descriptive name: GIVINOSTAT | 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 - (Phase 3): yes Therapeutic use (Phase 4): no | 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 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 | Not Recruiting | 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 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 | ||
| 11 | EUCTR2016-000401-36-DE (EUCTR) | 15/05/2017 | 28/10/2016 | 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 | Not Recruiting | Female: no Male: yes | 169 | Phase 3 | United States;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | EUCTR2016-000401-36-BE (EUCTR) | 27/01/2017 | 27/10/2016 | 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 | Not Recruiting | Female: no Male: yes | 242 | Phase 3 | United States;Serbia;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 15 | 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 | ||
| 16 | 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 | Not Recruiting | Female: no Male: yes | 192 | Phase 3 | United States;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy | |||
| 17 | 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 | |||
| 18 | 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 | 222 | Phase 3 | France;United States;Serbia;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy |
267. Hyper-IgD syndrome
Clinical trials : 11 / Drugs : 6 - (DrugBank : 1) / Drug target gene : 1 - Drug target pathways : 44
| 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 |