Givinostat (hydrochloride-monohydrate) ( DrugBank: Givinostat )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 107 | 若年性特発性関節炎 | 5 |
107. 若年性特発性関節炎
臨床試験数 : 447 / 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 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 |