WHO ICTRP trial
A Phase IIIb, Multicentre, Open-Label, Randomized, Controlled Study of the…
NL-OMON36625 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting
Key facts
| Trial ID | NL-OMON36625 |
|---|---|
| Public 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 |
| Scientific 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 - SPARK (Safety Paediatric efficAcy phaRmacokinetic with Kuvan®) |
| Primary sponsor | Merck Serono S.A. Geneva |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | Austria;Belgium;Czechia;Germany;Italy;Netherlands ;Turkey |
| Conditions | Phenylketonuria (PKU) Phenylketonuria (PKU);Phenylketonuria (PKU) |
| Interventions | Measuring Phe levels in blood (at the hospital + at home) blood sampling for PopPK BH4 responsiveness test ;Phenylketonuria (PKU) |
| Registration date | Jan 12, 2012 |
| Target size | 15 |
| Secondary IDs | 2009-015768-33;NCT01376908;NL32785.068.10 |
| Registry page | onderzoekmetmensen.nl |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: