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Study of the Effects of Fabrazyme Treatment on Lactation and Infants

NCT00230607 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-04-10

Study results available
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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

DRUG

agalsidase beta

Pharmaceutical form: powder for reconstitution Route of administration: intravenous

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-28
Primary Completion
2024-02-09
Completion
2024-02-09
FDA Drug
Yes

Countries

  • United States
  • Austria
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00230607 on ClinicalTrials.gov