RAvPAL-PEG ( DrugBank: rAvPAL-PEG )


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5

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
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
agemax
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gender
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PhaseCountries
1NCT01560286
(ClinicalTrials.gov)
May 20125/3/2012A Study to Evaluate Subcutaneously Administered rAvPAL-PEG in Patients With Phenylketonuria for 24 WeeksA Phase II, Multi-center, Open-label, Dose-finding Study to Evaluate Safety, Efficacy and Tolerability of Subcutaneously (SC) Administered rAvPAL-PEG in Patients With PKU for 24 WeeksPhenylketonuriaBiological: BMN 165 (rAvPAL-PEG)BioMarin PharmaceuticalNULLCompleted16 Years70 YearsAll24Phase 2United States
2NCT01212744
(ClinicalTrials.gov)
March 201129/9/2010Safety, Tolerability, and Efficacy Study of rAvPAL-PEG Administered Daily in Subjects With Phenylketonuria (PKU)A Phase 2, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Dose Levels of rAvPAL-PEG Administered Daily in Subjects With PhenylketonuriaPhenylketonuriaDrug: rAvPAL-PEGBioMarin PharmaceuticalNULLCompleted16 Years70 YearsAll16Phase 2United States
3NCT00924703
(ClinicalTrials.gov)
October 8, 200918/6/2009Long-Term Extension of Previous rAvPAL-PEG Protocols in Subjects With PKU (PAL-003)Long-term Extension of a Phase 2, Open-Label Dose-Finding Study to Evaluate the Safety, Efficacy, and Tolerability of Multiple Subcutaneous Doses of rAvPAL-PEG in Subjects With PKUPhenylketonuriaDrug: rAvPAL-PEGBioMarin PharmaceuticalNULLCompleted16 Years55 YearsAll68Phase 2United States
4NCT00925054
(ClinicalTrials.gov)
September 200917/6/2009Dose-Finding Study to Evaluate the Safety, Efficacy, & Tolerability of Multiple Doses of rAvPAL-PEG in Subjects With PKUPhase 2, Open-Label Dose-Finding Study to Evaluate the Safety, Efficacy, and Tolerability of Multiple Subcutaneous (SC) Doses of rAvPAL-PEG in Subjects With PKUPhenylketonuriaDrug: rAvPAL-PEG 0.001 mg/kg;Drug: rAvPAL-PEG 0.003 mg/kg;Drug: rAvPAL-PEG 0.01 mg/kg;Drug: rAvPAL-PEG 0.03 mg/kg;Drug: rAvPAL-PEG 0.1 mg/kgBioMarin PharmaceuticalNULLCompleted16 Years55 YearsAll40Phase 2United States
5NCT00634660
(ClinicalTrials.gov)
May 20086/3/2008Safety and Tolerability Study of rAvPAL-PEG to Treat PhenylketonuriaA Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single, Subcutaneous Doses of rAvPAL-PEG in Subjects With PhenylketonuriaPhenylketonuriaDrug: rAvPAL-PEGBioMarin PharmaceuticalNULLCompleted16 Years50 YearsAll25Phase 1United States