Trials / Terminated
TerminatedNCT00230607
Study of the Effects of Fabrazyme Treatment on Lactation and Infants
A Multicenter, Multinational Study of the Effects of Fabrazyme (Agalsidase Beta) Treatment on Lactation and Infants
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The study was planned for up to 2 years (24 months). Planned full participation for both mother and infant was 24 months, planned full participation of mother and development of infant was 24 months, while planned full participation of mother and no infant participation was 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | agalsidase beta | Pharmaceutical form: powder for reconstitution Route of administration: intravenous |
Timeline
- Start date
- 2006-05-28
- Primary completion
- 2024-02-09
- Completion
- 2024-02-09
- First posted
- 2005-10-03
- Last updated
- 2024-04-10
- Results posted
- 2024-04-10
Locations
5 sites across 3 countries: United States, Austria, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00230607. Inclusion in this directory is not an endorsement.