PROCYSBI ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
19ライソゾーム病4

19. ライソゾーム病


臨床試験数 : 899 薬物数 : 684 - (DrugBank : 99) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 182
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04246060
(ClinicalTrials.gov)
July 31, 202027/1/2020Observational Study to Assess the Quality of Life in Nephropathic Cystinosis PatientsMulticentre, Ambispective, Observational, Real Life Study to Assess the Quality of Life Effectiveness of Extended Release (ER) Oral Cysteamine Therapy (Procysbi) in Belgian Patients Suffering From Nephropathic CystinosisNephropathic CystinosisDrug: Cysteamine BitartrateChiesi SA/NVNULLEnrolling by invitationN/AN/AAll31Belgium
2EUCTR2012-002773-64-GB
(EUCTR)
22/01/201426/02/2013Study comparing the effectiveness of cysteamine bitartrate delayed release capsules (RP103) to Cystagon in Patients with Cystinosis(Adults and Children 12 years and older).A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis - Superiority, Safety and Efficacy Study of RP103 in Cystinosis Cystinosis
MedDRA version: 20.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: PROCYSBI
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: PROCYSBI
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon 50mg
Product Name: Cystagon
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon 150mg
Product Name: Cystagon
INN or Proposed INN: mercaptamine bitartrate
Horizon Pharma USA, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Belgium;Netherlands;Germany;Italy;United Kingdom
3EUCTR2012-002773-64-NL
(EUCTR)
15/08/201301/11/2013Study comparing the effectiveness of cysteamine bitartrate delayed-release capsules (RP103) in Patients with Cystinosis (Adult and Children 12 years and older)A Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis - Superiority, Safety and Efficacy Study of RP103 in Cystinosis Cystinosis
MedDRA version: 20.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: PROCYSBI
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate)
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: PROCYSBI
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate)
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon 50mg
Product Name: Cystagon
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon 150mg
Product Name: Cystagon
INN or Proposed INN: mercaptamine bitartrate
Horizon Pharma USA, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Belgium;Germany;Netherlands;Italy;United Kingdom
4EUCTR2010-018365-34-NL
(EUCTR)
14/12/201006/07/2010A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Nephropathic CystinosisA Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Nephropathic Cystinosis - RP103-04 Cystinosis
MedDRA version: 20.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: PROCYSBI
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: PROCYSBI
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Horizon Pharma USA, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Netherlands