RP103 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
8ハンチントン病1
19ライソゾーム病15

8. ハンチントン病


臨床試験数 : 242 薬物数 : 205 - (DrugBank : 62) / 標的遺伝子数 : 85 - 標的パスウェイ数 : 159
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02101957
(ClinicalTrials.gov)
October 201025/3/2014Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103)Huntington's DiseaseDrug: RP103;Drug: PlaceboUniversity Hospital, AngersNULLActive, not recruiting18 Years65 YearsBoth96Phase 2/Phase 3France

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
1EUCTR2012-002773-64-IT
(EUCTR)
12/02/201421/11/2013A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-release Capsules (RP103) in Patients withCystinosisA Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-release Capsules (RP103) in Patients withCystinosis - RP103-07 Cystinosis
MedDRA version: 16.1;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]
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: CYSTAGON
Product Name: Cystagon
INN or Proposed INN: Cystagon
Other descriptive name: Cysteamine bitartrate
Trade Name: CYSTAGON
Product Name: Cystagon
INN or Proposed INN: Cystagon
Other descriptive name: Cysteamine bitartrate
Raptor Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Belgium;Netherlands;Germany;United Kingdom;Italy
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-BE
(EUCTR)
21/01/201419/04/2013A Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with CystinosisA Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis - RP103-07 Cystinosis
MedDRA version: 14.1;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]
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
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
Raptor Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;France;Belgium;Netherlands;Germany;United Kingdom;Italy
4EUCTR2012-002773-64-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
5EUCTR2012-002773-64-FR
(EUCTR)
03/06/201328/09/2015A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-release Capsules (RP103) in Patients withCystinosisA Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-release Capsules (RP103) in Patients withCystinosis - RP103-07 Cystinosis
MedDRA version: 18.0;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]
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon
Product Name: Cystagon
INN or Proposed INN: MERCAPTAMINE bitartrate
Raptor Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;France;Belgium;Netherlands;Italy;United Kingdom
6NCT01733316
(ClinicalTrials.gov)
January 31, 201316/11/2012Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-Release Capsules (RP103) in CystinosisA Long-Term, Open-Label, Safety, Tolerability and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients With CystinosisCystinosisDrug: RP103;Drug: Cystagon®Horizon Pharma USA, Inc.NULLCompleted12 YearsN/AAll41Phase 3United States;Belgium;France;Italy;Netherlands;United Kingdom
7NCT01744782
(ClinicalTrials.gov)
December 20, 20125/12/2012Safety/Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Cysteamine Treatment Naive Patients With CystinosisAn Open-Label, Safety and Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Cysteamine Treatment Naïve Patients With CystinosisCystinosisDrug: RP103Horizon Pharma USA, Inc.NULLCompletedN/A6 YearsAll17Phase 3United States;Brazil
8EUCTR2010-018365-34-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
9EUCTR2009-017882-42-NL
(EUCTR)
19/10/201025/06/2010A Randomized, Crossover, Pharmacokinetic and PharmacodynamicStudy to Determine the Safety and Efficacy of Cysteamine BitartrateDelayed-release Capsules (RP103), Compared to Cystagon® in Patientswith Nephropathic CystinosisA Randomized, Crossover, Pharmacokinetic and PharmacodynamicStudy to Determine the Safety and Efficacy of Cysteamine BitartrateDelayed-release Capsules (RP103), Compared to Cystagon® in Patientswith Nephropathic Cystinosis Cystinosis
MedDRA version: 12.1;Level: LLT;Classification code 10011777;Term: Cystinosis
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon
Raptor Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
20Netherlands;France
10EUCTR2010-020098-18-FR
(EUCTR)
09/09/201012/07/2010CrYSTobs A cohort of patients with cystinosis : compliance to cysteamine and neurological complicationsAn auxiliary study to Raptor RP103 03 and RP103 04 - CrYSTobsCrYSTobs A cohort of patients with cystinosis : compliance to cysteamine and neurological complicationsAn auxiliary study to Raptor RP103 03 and RP103 04 - CrYSTobs nephropatic cystinosis
MedDRA version: 12.1;Level: LLT;Classification code 10011777;Term: Cystinosis
Trade Name: CYSTAGON
Product Name: CYSTAGON
INN or Proposed INN: MERCAPTAMINE BITARTRATE
Other descriptive name: CYSTEAMINE
Product Name: RP 103
INN or Proposed INN: MERCAPTAMINE BITARTRATE
Other descriptive name: CYSTEAMINE
Product Name: RP 103
INN or Proposed INN: MERCAPTAMINE BITARTRATE
Other descriptive name: CYSTEAMINE
HOSPICES CIVILS DE LYONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
11NCT01197378
(ClinicalTrials.gov)
August 27, 20103/9/2010Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients With CystinosisCystinosisDrug: Cysteamine Bitartrate Delayed-release CapsulesHorizon Pharma USA, Inc.NULLCompleted1 YearN/AAll60Phase 3United States;France;Netherlands
12EUCTR2009-017882-42-FR
(EUCTR)
12/08/201014/06/2010A Randomized, Crossover, Pharmacokinetic and PharmacodynamicStudy to Determine the Safety and Efficacy of Cysteamine BitartrateDelayed-release Capsules (RP103), Compared to Cystagon® in Patientswith Nephropathic CystinosisA Randomized, Crossover, Pharmacokinetic and PharmacodynamicStudy to Determine the Safety and Efficacy of Cysteamine BitartrateDelayed-release Capsules (RP103), Compared to Cystagon® in Patientswith Nephropathic Cystinosis Cystinosis
MedDRA version: 12.1;Level: LLT;Classification code 10011777;Term: Cystinosis
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon
Raptor Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
Phase 3France;Netherlands
13NCT01000961
(ClinicalTrials.gov)
June 201022/10/2009Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With CystinosisA Randomized, Crossover Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients With Nephropathic CystinosisCystinosisDrug: Cystagon® (Cysteamine Bitartrate);Drug: Cysteamine Bitartrate Delayed-release Capsules (RP103)Horizon Pharma USA, Inc.NULLCompleted6 YearsN/AAll43Phase 3United States;France;Netherlands
14NCT00872729
(ClinicalTrials.gov)
May 200927/3/2009Pilot Study of Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of RP103 Compared to Cystagon® in Patients With CystinosisA Pilot Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cysteamine Bitartrate (Cystagon®) in Patients With Nephropathic CystinosisCystinosisDrug: Cystagon®;Drug: RP103Horizon Pharma USA, Inc.NULLCompletedN/AN/AAll9Phase 1/Phase 2United States
15EUCTR2010-018365-34-FR
(EUCTR)
18/06/2010A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Nephropathic Cystinosis - RP103-04A 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: 12.1;Level: LLT;Classification code 10011777;Term: Cystinosis
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Raptor Therapeutics Inc.NULLNAFemale: yes
Male: yes
20Phase 3France;Netherlands