NCT00230607TerminatedPhase 4
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
Source: ClinicalTrials.gov · Last updated 10 Apr 2024
Reason given: Per FDA decision, the 2003 Post Marketing commitment has been fulfilled.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 29 Sept 2005
- Start date
- 28 May 2006
- Primary completion date
- 9 Feb 2024
- Lead sponsor
- Genzyme, a Sanofi Company
- Diseases
- Fabry disease
- NCT number
- NCT00230607
- EudraCT number
- 2006-001910-33
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The mother and infant were excluded from this study if the mother received an investigational drug within 30 days prior to study enrollment.
Who the study is looking for
- Mothers that met the following criteria were enrolled in this study:
- provided signed written informed consent to participate in this study,
- be enrolled in the Fabry Registry and received Fabrazyme while lactating,
- agreed to adhere to the Fabry Registry recommended schedule of assessments for medical history, pregnancy outcome, genotyping, and antibody testing, and
- agreed to adhere to the schedule of evaluations for this study.
- Infants that met the following criteria were enrolled in this study:
- had the signed written informed consent of the parent(s)/legal guardian(s) to participate in this study,
- born to a mother who was receiving Fabrazyme during lactation,
- received breast milk from the mother, and
- had the agreement of the parent(s)/legal guardian(s) to adhere to the schedule of evaluations for this study.
Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| investigational site number 04Bodamer | Marl | Austria | Unknown status |
| investigational site number 03Waldek | Salford | United Kingdom | Unknown status |
| - | Decatur | United States | Unknown status |
| - | Fairfax | United States | Unknown status |
| investigational site number 01Rhead | Milwaukee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.