Trials / Completed
CompletedNCT00778206
PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,887 (actual)
- Sponsor
- BioMarin Pharmaceutical · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety of long-term treatment with Kuvan.
Detailed description
The PKUDOS program is a voluntary, multicenter, strictly observational program for patients with PKU who have either received Kuvan therapy, or currently receive Kuvan, or intend to begin receiving Kuvan therapy within 90 days of entering the registry.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Kuvan | -Recommended post-partum Assessments include: collection of baby's plasma at Birth, 1 Month and 6 months, and collection of mother's plasma and expressed breast milk sample at 1 Month. |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2021-01-29
- Completion
- 2021-01-29
- First posted
- 2008-10-23
- Last updated
- 2022-10-12
Locations
45 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00778206. Inclusion in this directory is not an endorsement.