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A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms

NCT00701415 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2016-06-29

Study results available
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Summary

The purpose of this study was to determine whether 2 alternative dosing regimens of Fabrazyme (Agalsidase beta) (1.0 mg/kg every 4 weeks or 0.5 mg/kg every 2 weeks) were effective in treatment-naïve pediatric participants without severe symptoms. Participants were to be treated for 5 years.

Conditions

Interventions

BIOLOGICAL

Agalsidase beta

Powder for concentrate for solution for infusion 1.0 mg/kg/4 weeks

BIOLOGICAL

Agalsidase beta

Powder for concentrate for solution for infusion 0.5 mg/kg/2 weeks

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Czechia
  • Netherlands
  • Norway
  • Poland
  • 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 NCT00701415 on ClinicalTrials.gov