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
Showing 1 to 6 of 6 trials
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 |
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1 | NCT01732471 (ClinicalTrials.gov) | November 201220121100 | 19/11/201220121119 | Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria 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 Kuvan (Sapropterin Dihydrochloride) After 6 Weeks of Treatment in Patients of 4 to 18 Years of Age With Phenylketonuria Who Have Elevated Blood Phenylalanine Levels 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 201120110600 | 23/6/201120110623 | Phenylketonuria, Oxidative Stress, and BH4 | The Ability of Kuvan® (Sapropterin Dihydrochloride) to Prevent Meal-induced Lipid Peroxidation and Endothelial Dysfunction in Patients With Phenylketonuria: a Pilot Study 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 201120110100 | 10/1/201120110110 | Evaluation of Behavior, Executive Function, Neurotransmitter Function and Genomic Expression Kuvan Nonresponders Evaluation of Behavior, Executive Function, Neurotransmitter Function and Genomic Expression Kuvan N ... | Evaluation of Behavior, Executive Function, Neurotransmitter Function and Genomic Expression in PKU Nonresponders to Kuvan® (Sapropterin Dihydrochloride) 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) | 00000000 | 02/06/200920090602 | A Phase IV, prospective, open-label, uncontrolled, single-centre cohort trial to be conducted in Norway to assess the responsiveness of subjects with phenylketonuria (PKU) to treatment with Kuvan® 20 mg/kg/day for 7 days. - Response to Kuvan® in subjects with PKU from a single centre in Norway 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 Norway to assess the responsiveness of subjects with phenylketonuria (PKU) to treatment with Kuvan® 20 mg/kg/day for 7 days. - Response to Kuvan® in subjects with PKU from a single centre in Norway 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) (classic or mild PKU, or mild hyperphenylalaninemia (HPA)). MedDRA version: 9.1;Level: LLT;Classification code 10034872;Term: Phenylketonuria MedDRA version: 9.1;Classification code 10034873;Term: Phenylketonuria (PKU) MedDRA version: 9.1;Level: PT;Classification code 10034871;Term: Phenylalaninemia 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) | 00000000 | 26/06/201520150626 | Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria 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 Kuvan (Sapropterin Dihydrochloride) After 6 Weeks of Treatment in Patients of 4 to 18 Years of Age With Phenylketonuria Who Have Elevated Blood Phenylalanine Levels 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) | 00000000 | 24/11/202120211124 | BH4 (Kuvan©) treatment in Phenylketonuria - comparing different practices of dosing regimens | Tetrahydrobiopterin (BH4) treatment in Phenylketonuria - comparing different practices of dosing regimen - BH4 dose Tetrahydrobiopterin (BH4) treatment in Phenylketonuria - comparing different practices of dosing reg ... | Phenylketonuria (PKU; OMIM 261600);Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] Phenylketonuria (PKU; OMIM 261600);Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseas ... | Trade Name: Kuvan® (sapropterin dihydrochloride) Product Name: Kuvan® (sapropterin dihydrochloride) Product Code: A16AX07 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 |