Cysteamine ( DrugBank: Cysteamine )

4 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	2
19	ライソゾーム病	27
21	ミトコンドリア病	2
299	嚢胞性線維症	7

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

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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	NCT02101957 (ClinicalTrials.gov)	October 2010	25/3/2014	Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103)		Huntington's Disease	Drug: RP103;Drug: Placebo	University Hospital, Angers	NULL	Active, not recruiting	18 Years	65 Years	Both	96	Phase 2/Phase 3	France
2	EUCTR2010-019444-39-FR (EUCTR)	18/06/2010	04/05/2010	Essai multicentrique de traitement de la maladie de Huntington par la cystéamine - CYST-HD	Essai multicentrique de traitement de la maladie de Huntington par la cystéamine - CYST-HD	Maladie de Huntington. MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington ...	Product Name: Cysteamine Bitartrate Product Code: RP 103	Centre Hospitalier Universitaire d'Angers	NULL	Not Recruiting			Female: yes Male: yes	96	Phase 2;Phase 3	France

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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

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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	EUCTR2018-002984-24-BE (EUCTR)	11/02/2021	02/10/2020	Open-label, Single-arm, Multicenter Study to Assess the Safety of Cystadrops® in Pediatric Cystinosi ...	Study to Assess the Safety of Cystadrops® in Pediatric Cystinosis Patients from 6 Months to Less Tha ...	Nephropatic Cystinosis patients with corneal cystine crystal deposits MedDRA version: 20.0;Level: LL ...	Trade Name: Cystadrops Product Name: Cystadrops INN or Proposed INN: Cysteaminehydrochloride Other desc ...	Recordati Rare Diseases	NULL	Not Recruiting			Female: yes Male: yes	5	Phase 3	France;Belgium;Germany;Italy;United Kingdom
2	NCT04246060 (ClinicalTrials.gov)	July 31, 2020	27/1/2020	Observational Study to Assess the Quality of Life in Nephropathic Cystinosis Patients	Multicentre, Ambispective, Observational, Real Life Study to Assess the Quality of Life Effectivenes ...	Nephropathic Cystinosis	Drug: Cysteamine Bitartrate	Chiesi SA/NV	NULL	Enrolling by invitation	N/A	N/A	All	31		Belgium
3	EUCTR2018-002984-24-DE (EUCTR)	30/06/2020	10/01/2020	Open-label, Single-arm, Multicenter Study to Assess the Safety of Cystadrops® in Pediatric Cystinosi ...	Study to Assess the Safety of Cystadrops® in Pediatric Cystinosis Patients from 6 Months to Less Tha ...	Nephropatic Cystinosis patients with corneal cystine crystal deposits MedDRA version: 20.0;Level: LL ...	Trade Name: Cystadrops Product Name: Cystadrops INN or Proposed INN: Cysteaminehydrochloride Other desc ...	Recordati Rare Diseases	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	5	Phase 3	France;Germany;United Kingdom
4	EUCTR2018-002984-24-GB (EUCTR)	25/10/2019	15/07/2019	Open-label, Single-arm, Multicenter Study to Assess the Safety of, Cystadrops® in Pediatric Cystinos ...	Open-label, Single-arm, Multicenter Study to Assess the Safety of Cystadrops® in Pediatric Cystinosi ...	Corneal cystine crystal deposits in pediatric patients withnephropathic cystinosis from 6 months to ...	Trade Name: Cystadrops Product Name: Cystadrops INN or Proposed INN: Mercaptamine hydrochloride Other d ...	RECORDATI Rare Diseases SARL	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	5	Phase 3	France;United Kingdom
5	EUCTR2013-003228-35-ES (EUCTR)	16/07/2014	12/11/2013	Study of the preliminary efficacy and safety of topical cysteamineformulated in viscous solution in ...	Study of the preliminary efficacy and safety of topical cysteamineformulated in viscous solution in ...	Cystinosis MedDRA version: 16.1;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ ...	Product Name: cysteamine(mercaptamine) viscous solution INN or Proposed INN: Mercaptamine Other descri ...	Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)	NULL	Not Recruiting			Female: yes Male: yes			Spain
6	EUCTR2012-002773-64-IT (EUCTR)	12/02/2014	21/11/2013	A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-rele ...	A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-rele ...	Cystinosis MedDRA version: 16.1;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ ...	Product Name: Cysteaminebitartrate (INN: mercaptamine bitartrate ) Product Code: RP103 INN or Proposed ...	Raptor Therapeutics Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	France;United States;Belgium;Netherlands;Germany;United Kingdom;Italy
7	EUCTR2012-002773-64-GB (EUCTR)	22/01/2014	26/02/2013	Study comparing the effectiveness of cysteaminebitartrate delayed release capsules (RP103) to Cystag ...	A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-rele ...	Cystinosis MedDRA version: 20.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ ...	Trade Name: PROCYSBI Product Name: Cysteaminebitartrate (INN: mercaptamine bitartrate ) Product Code: ...	Horizon Pharma USA, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	France;United States;Belgium;Netherlands;Germany;Italy;United Kingdom
8	EUCTR2012-002773-64-BE (EUCTR)	21/01/2014	19/04/2013	A Long-Term Open-Label, Safety and Superior Effectiveness Study of CysteamineBitartrate Delayed-rele ...	A Long-Term Open-Label, Safety and Superior Effectiveness Study of CysteamineBitartrate Delayed-rele ...	Cystinosis MedDRA version: 14.1;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ ...	Product Name: Cysteaminebitartrate (INN: mercaptamine bitartrate ) Product Code: RP103 INN or Proposed ...	Raptor Therapeutics Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	United States;France;Belgium;Netherlands;Germany;United Kingdom;Italy
9	EUCTR2012-002773-64-NL (EUCTR)	15/08/2013	01/11/2013	Study comparing the effectiveness of cysteaminebitartrate delayed-release capsules (RP103) in Patien ...	A Long-Term Open-Label, Safety and Superior Effectiveness Study of CysteamineBitartrate Delayed-rele ...	Cystinosis MedDRA version: 20.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ ...	Trade Name: PROCYSBI Product Name: Cysteaminebitartrate (INN: mercaptamine bitartrate) Product Code: R ...	Horizon Pharma USA, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	France;United States;Belgium;Germany;Netherlands;Italy;United Kingdom
10	EUCTR2012-002773-64-FR (EUCTR)	03/06/2013	28/09/2015	A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-rele ...	A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-rele ...	Cystinosis MedDRA version: 18.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ ...	Product Name: Cysteaminebitartrate (INN: mercaptamine bitartrate ) Product Code: RP103 INN or Proposed ...	Raptor Therapeutics Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	United States;France;Belgium;Netherlands;Italy;United Kingdom

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21. ミトコンドリア病

臨床試験数 : 39 / 薬物数 : 42 - (DrugBank : 32) / 標的遺伝子数 : 47 - 標的パスウェイ数 : 67

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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	NCT02473445 (ClinicalTrials.gov)	May 19, 2015	10/6/2015	A Long-term Extension of Study RP103-MITO-001 (NCT02023866) to Assess CysteamineBitartrate Delayed-r ...	A Long-Term Open-Label Extension Study of RP103-MITO-001 to Assess the Safety, Tolerability and Effi ...	Mitochondrial Diseases	Drug: Cysteamine Bitartrate	Horizon Pharma USA, Inc.	NULL	Terminated	6 Years	17 Years	All	22	Phase 2	United States
2	NCT02023866 (ClinicalTrials.gov)	May 2014	17/12/2013	Open-Label, Dose-Escalating Study Assessing Safety, Tolerability, Efficacy, of RP103 in Mitochondria ...	An Open-Label, Dose-Escalating Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics ...	Inherited Mitochondrial Disease, Including Leigh Syndrome	Drug: Cysteamine Bitartrate	Horizon Pharma USA, Inc.	NULL	Completed	6 Years	17 Years	All	36	Phase 2	United States

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299. 嚢胞性線維症

臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174

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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	EUCTR2017-001259-29-GB (EUCTR)	12/03/2019	21/12/2018	A study to establish the tolerabilty and adverse effects in people with a severe form of Cystic Fibr ...	A PHASE 1B/2A STUDY TO ASSESS THE TOLERABILITY AND ADVERSE EFFECT PROFILE OF CYSTEAMINE(CYSTAGON) IN ...	DeltaF508 Homozygous Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Ter ...	Trade Name: Cystagon Product Name: Cystagon INN or Proposed INN: cysteaminebitartrate Other descriptive ...	University of LIverpool	NULL	Not Recruiting			Female: yes Male: yes	44	Phase 1;Phase 2	United Kingdom
2	EUCTR2015-004986-99-IT (EUCTR)	11/01/2017	06/09/2016	A study to identify whether it is safe, if it works, and how much and how often cysteamineshould be ...	A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose ...	exacerbation of Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10070608;Term: In ...	Product Name: cysteamine bitartrate	NovaBiotics, Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Netherlands;United Kingdom;Italy
3	NCT03000348 (ClinicalTrials.gov)	December 2016	11/12/2016	A Study of the Dosing, Efficacy, and Safety of Oral Cysteaminein Adult Patients With Cystic Fibrosis ...	A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose ...	Cystic Fibrosis	Drug: Cysteamine;Drug: Placebo Oral Capsule	NovaBiotics Ltd.	Agility Clinical, Inc.;PSR Group B.V.	Completed	18 Years	N/A	All	91	Phase 2	United States;Italy;United Kingdom
4	EUCTR2015-004986-99-GB (EUCTR)	31/10/2016	06/09/2016	A study to identify whether it is safe, if it works, and how much and how often cysteamineshould be ...	A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose ...	exacerbation of Cystic Fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C ...	Product Name: cysteamine bitartrate	NovaBiotics, Ltd	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	United States;Netherlands;Italy;United Kingdom
5	NCT02212431 (ClinicalTrials.gov)	August 2014	7/8/2014	First Study of Oral Cysteamine in Cystic Fibrosis	An Open Label Investigation of the Tolerability and Pharmacokinetics of Oral Cysteaminein Adults Wit ...	Cystic Fibrosis	Drug: Cysteamine	University of Aberdeen	Cystic Fibrosis Trust;NHS Grampian;University of Huddersfield;Cystic Fibrosis Trust;NHS Grampian;Uni ...	Completed	18 Years	N/A	Both	10	Phase 1/Phase 2	United Kingdom
6	EUCTR2014-000284-40-GB (EUCTR)	05/06/2014	29/04/2014	Cysteamine in Cystic Fibrosis	An open label investigation of the tolerability and pharmacokinetics of oral cysteaminein adults wit ...	Cystic Fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ...	Trade Name: Cystagon (cysteaminebitartrate) immediate-release capsules Product Name: Cystagon (cystea ...	University of Aberdeen	NHS Grampian	Not Recruiting			Female: yes Male: yes	12	Phase 1;Phase 2	United Kingdom
7	EUCTR2013-001258-82-IT (EUCTR)	12/09/2013	29/07/2013	Phase II clinical study for the therapy of cystic fibrosis patients with aspecific mutation	A phase II pilot clinical study of experimental research to evaluate thefunctional rescue of CFTR pr ...	Cystic fibrosis patients with F508del-CFTR in homozygous or compound heterozygous with Class I or II ...	Trade Name: Cystagon Product Name: Cysteamine bitartrate (Cystagon) Product Code: EMEA/H/C/000125	European Institute for Cystic Fibrosis Research (IERFC)	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Italy

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