Tetrahydrobiopterin ( DrugBank: Tetrahydrobiopterin )

1 disease

告示番号	疾患名（ページ内リンク）	臨床試験数
240	フェニルケトン尿症	26

240. フェニルケトン尿症

臨床試験数 : 143 / 薬物数 : 90 - (DrugBank : 10) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 5

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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	NCT04375592 (ClinicalTrials.gov)	February 1, 2021	21/4/2020	Acceptability and Tolerance of a Ready-to-use Protein Substitute in Tablet Form for the Dietary Mana ...	XPhe Minis - Acceptability and Tolerance Market Research	Phenylketonurias;Hyperphenylalaninaemia;Tetrahydrobiopterin Deficiency	Dietary Supplement: Phenylalanine-free protein substitute in tablet form (XPhe minis)	metaX Institut fuer Diatetik GmbH	Birmingham Children's Hospital	Recruiting	7 Years	18 Years	All	10		United Kingdom
2	NCT04014712 (ClinicalTrials.gov)	August 2019	3/7/2019	O2 Transport and Utilization in Health and Lung Disease	Role of Nitric Oxide Coupling in Muscle Dysfunction With COPD	COPD;Tetrahydrobiopterin Deficiency;Oxidative Stress	Drug: Tetrahydrobiopterin;Drug: Placebo oral tablet	University of Massachusetts, Amherst	NULL	Not yet recruiting	18 Years	85 Years	All	30	Phase 1	United States
3	NCT03519711 (ClinicalTrials.gov)	June 24, 2018	11/4/2018	A Study of CNSA-001 in Primary Tetrahydrobiopterin(BH4) Deficient Participants With Hyperphenylalani ...	A Phase 1/2, Open-Label, Randomized Parallel Arm, Intra-patient Dose Escalation Study to Evaluate th ...	BH4 Deficiency;Hyperphenylalaninemia	Drug: CNSA-001	PTC Therapeutics	NULL	Completed	12 Months	N/A	All	6	Phase 1/Phase 2	United States;Germany
4	NCT03864029 (ClinicalTrials.gov)	October 10, 2017	22/2/2019	Retrospective Observational Safety Effectiveness With Kuvan in hpA	An Observational Study Research to Collect the Effectiveness and Safety Data of KUVAN® Retrospective ...	Tetrahydrobiopterin Deficiency	Drug: KUVAN	BioMarin Pharmaceutical	Quintiles, Inc.	Completed	N/A	N/A	All	26		China
5	EUCTR2009-015844-41-ES (EUCTR)	31/10/2013	16/01/2014	A Study of the Long-term Effects on Mental Abilities of 4 to 5 Year-old Children with a Disease Caus ...	A Phase IV Open-Label, Single-Cohort Study of the Long-Term Neurocognitive Outcomes in 4 to 5 Year-O ...	Phenylketonuria MedDRA version: 16.1;Level: LLT;Classification code 10034873;Term: Phenylketonuria ( ...	Trade Name: Kuvan INN or Proposed INN: SAPROPTERIN Other descriptive name: tetrahydrobiopterin	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 4	Spain;Germany;United Kingdom
6	EUCTR2009-015844-41-DE (EUCTR)	10/09/2013	13/06/2013	A Study of the Long-term Effects on Mental Abilities of 4 to 5 Year-old Children with a Disease Caus ...	A Phase IV Open-Label, Single-Cohort Study of the Long-Term Neurocognitive Outcomes in 4 to 5 Year-O ...	Phenylketonuria MedDRA version: 20.0;Level: LLT;Classification code 10034873;Term: Phenylketonuria ( ...	Trade Name: Kuvan INN or Proposed INN: SAPROPTERIN Other descriptive name: tetrahydrobiopterin	BioMarin International Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	Spain;Germany;Italy;United Kingdom
7	EUCTR2009-015844-41-IT (EUCTR)	02/09/2013	25/06/2013	A Study of the Long-term Effects on Mental Abilities of 4 to 5 Year-old Children with a Disease Caus ...	A Phase IV Open-Label, Single-Cohort Study of the Long-Term Neurocognitive Outcomes in 4 to 5 Year-O ...	Phenylketonuria MedDRA version: 14.1;Level: LLT;Classification code 10034873;Term: Phenylketonuria ( ...	Trade Name: Kuvan INN or Proposed INN: SAPROPTERIN Other descriptive name: tetrahydrobiopterin	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 4	Spain;Germany;United Kingdom;Italy
8	EUCTR2009-015844-41-GB (EUCTR)	25/07/2013	13/06/2013	A Study of the Long-term Effects on Mental Abilities of 4 to 5 Year-old Children with a Disease Caus ...	A Phase IV Open-Label, Single-Cohort Study of the Long-Term Neurocognitive Outcomes in 4 to 5 Year-O ...	Phenylketonuria MedDRA version: 19.0;Level: LLT;Classification code 10034873;Term: Phenylketonuria ( ...	Trade Name: Kuvan Product Name: Kuvan INN or Proposed INN: SAPROPTERIN Other descriptive name: tetrahyd ...	BioMarin International Ltd.	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 4	Spain;Germany;Italy;United Kingdom
9	NCT01617070 (ClinicalTrials.gov)	May 2012	8/6/2012	Effects of Kuvan on Melatonin Secretion	Pilot Study to Evaluate Melatonin Secretion as a Marker of Decreased Serotonin in Individuals With P ...	Phenylketonuria (PKU)	Drug: Kuvan;Dietary Supplement: Large Neutral Amino Acid Therapy	University of Southern California	BioMarin Pharmaceutical	Completed	18 Years	N/A	All	10	Phase 4	United States
10	EUCTR2009-015768-33-DE (EUCTR)	20/05/2011	04/11/2010	Safety Paediatric efficAcy phaRmacokinetic with Kuvan®	A Phase IIIb, Multicentre, Open-Label, Randomized, Controlled Study of the Efficacy, Safety, and Pop ...	Phenylketonuria MedDRA version: 19.0;Level: LLT;Classification code 10034873;Term: Phenylketonuria ( ...	Trade Name: Kuvan Product Name: Sapropterin Dihydrocholoride Product Code: NAP INN or Proposed INN: SAP ...	BioMarin International Ltd	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 3	Portugal;Czech Republic;Slovakia;Belgium;Turkey;Austria;Netherlands;Germany;Italy;United Kingdom

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