Clinical trial
Kuvan® in Phenylketonuria Patients Less Than 4 Years Old
NCT01376908 · BioMarin Pharmaceutical, Industry · Completed
Key facts
| NCT number | NCT01376908 |
|---|---|
| Title | Kuvan® in Phenylketonuria Patients Less Than 4 Years Old |
| Official title | A Phase IIIb, Multicentre, Open-Label, Randomized, Controlled Study of the Efficacy, Safety, and Population Pharmacokinetics of Sapropterin Dihydrochloride (Kuvan®) in Phenylketonuria (PKU) Patients <4 Years Old. |
| Acronym | SPARK |
| Lead sponsor | BioMarin Pharmaceutical, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Phenylketonuria |
| Intervention type | Drug, Other |
| Interventions | Kuvan®, Phenylalanine (Phe)-restricted diet |
| Enrollment | 56 |
| Start date | Jun 1, 2011 |
| Primary completion | Jul 1, 2014 |
| Completion | Feb 17, 2017 |
| First posted | Jun 20, 2011 |
| Last update posted | Sep 15, 2017 |
| Countries | Austria, Belgium, Czechia, Germany, Italy, Netherlands, Slovakia, Turkey (Türkiye), United Kingdom |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: