drugset / Trial / NCT00484991

Sapropterin Expanded Access Program

NCT00484991

Expanded access Approved for marketing BioMarin Pharmaceutical

Summary

The Purpose of this study is to provide patients with hyperphenylalaninemia (HPA) due to Phenylketonuria (PKU) access to sapropterin dihydrochloride and to collect more information about the safety of the drug in an expanded access program (EAP) until commercial product is available.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject sapropterin Unknown 20 mg/kg Oral

Indications