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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-003341-18-CZ
(EUCTR)
14/10/201105/09/2011NAPAn 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.NULLNot RecruitingFemale: yes
Male: yes
3Czech Republic
2EUCTR2010-019094-15-BE
(EUCTR)
07/12/201020/05/2010A 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 treatmentA 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.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2Czech Republic;Slovenia;Spain;Belgium;Italy
3EUCTR2010-019094-15-ES
(EUCTR)
06/09/201026/05/2010Estudio 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 treatmentEstudio 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.NULLNot RecruitingFemale: yes
Male: yes
20Czech Republic;Slovenia;Spain;Italy
4EUCTR2010-019094-15-SI
(EUCTR)
17/08/201022/06/2010A 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 treatmentA 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.NULLNot RecruitingFemale: yes
Male: yes
20Czech Republic;Slovenia;Spain;Italy
5EUCTR2010-019094-15-CZ
(EUCTR)
01/07/201017/05/2010A 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 treatmentA 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.NULLNot RecruitingFemale: yes
Male: yes
20Czech Republic;Slovenia;Spain;Italy