Kuvan® (sapropterin dihydrochloride)

( DrugBank: - / KEGG DRUG: - )

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	6

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	NCT01732471 (ClinicalTrials.gov)	November 2012	19/11/2012	Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan®in Subjects With Phenylketonur ...	A Phase III Non-comparative Open-label Clinical Study to Evaluate the Response to and Safety of Kuva ...	Phenylketonuria	Drug: Kuvan®	Merck KGaA	NULL	Completed	4 Years	18 Years	All	90	Phase 3	Germany
2	NCT01395394 (ClinicalTrials.gov)	June 2011	23/6/2011	Phenylketonuria, Oxidative Stress, and BH4	The Ability of Kuvan® (Sapropterin Dihydrochloride)to Prevent Meal-induced Lipid Peroxidation and En ...	Phenylketonuria	Drug: Kuvan;Other: Meal Challenge	Emory University	NULL	Terminated	10 Years	45 Years	All	12	Phase 2	United States
3	NCT01274026 (ClinicalTrials.gov)	January 2011	10/1/2011	Evaluation of Behavior, Executive Function, Neurotransmitter Function and Genomic Expression Kuvan N ...	Evaluation of Behavior, Executive Function, Neurotransmitter Function and Genomic Expression in PKU ...	Phenylketonuria;Behavior and Behavior Mechanisms;PAH Gene Expression	Drug: sapropterin dihydrochloride	Tulane University School of Medicine	BioMarin Pharmaceutical	Completed	2 Years	N/A	All	21		United States
4	EUCTR2009-012978-12-NO (EUCTR)		02/06/2009	A Phase IV, prospective, open-label, uncontrolled, single-centre cohort trial to be conducted in Nor ...	A Phase IV, prospective, open-label, uncontrolled, single-centre cohort trial to be conducted in Nor ...	Hyperphenylalaninemia (HPA) in adults and children >=16 years of age with phenylketonuri (PKU) (clas ...	Trade Name: Kuvan® (sapropterin dihydrochloride) INN or Proposed INN: sapropterin	Merck Serono, an affiliate of E. Merck AB	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Norway
5	EUCTR2015-001650-15-Outside-EU/EEA (EUCTR)		26/06/2015	Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan®in Subjects With Phenylketonur ...	A Phase III Non-comparative Open-label Clinical Study to Evaluate the Response to and Safety of Kuva ...	Phenylketonuria;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]	Trade Name: Kuvan 100mg soluble tablet Product Name: Sapropterin Dihydrocholoride	Merck Serono Middle East FZ-LLC	NULL	NA			Female: yes Male: yes	90	Phase 3	Ukraine;Russian Federation
6	EUCTR2021-003777-63-NL (EUCTR)		24/11/2021	BH4 (Kuvan©) treatment in Phenylketonuria - comparing different practices of dosing regimens	Tetrahydrobiopterin (BH4) treatment in Phenylketonuria - comparing different practices of dosing reg ...	Phenylketonuria (PKU; OMIM 261600);Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseas ...	Trade Name: Kuvan® (sapropterin dihydrochloride) Product Name: Kuvan® (sapropterin dihydrochloride) Pr ...	University Medical Center Groningen	NULL	NA			Female: yes Male: yes	28	Phase 4	Netherlands

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