Status:
COMPLETED
A Study of Fabrazyme in Pediatric Patients With Fabry Disease
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Fabry Disease
Eligibility:
All Genders
7-15 years
Phase:
PHASE2
Brief Summary
People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. This enzyme helps to break down and remove certain types of fatt...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patient or legal guardian must provide written informed consent
- Patients must have a clinical diagnosis of Fabry disease and active Fabry disease (clinical signs and symptoms)
- Patients must be at least 7 years of age but no older than 15 years of age at time of enrollment
- Patients must be Tanner Stage ≤ III
- Female patients must have a negative pregnancy test prior to each infusion and use a medically accepted form of contraception throughout the study
- Exclusion Criteria:
- Patient has a clinically significant organic disease (with the exception of symptoms relating to Fabry disease) that in the opinion of the investigator would preclude participation in the trial
- Patient has participated in a study employing investigational drug within 30 days of the start of this study
- Patient has received prior treatment with enzyme replacement therapy
- Patient is unable to comply with the clinical protocol
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00074958
Start Date
October 1 2002
End Date
July 1 2005
Last Update
April 2 2015
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arizona
Tucson, Arizona, United States, 85724
2
Hopital Edouard Herriot
Lyon, France, Cedex 03
3
Hopital de la Timone Enfants
Marseille, France, Cedex 05
4
Hopital Europeen Georges Pompidou
Paris, France, Cedex 15