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Study of the Effects of Fabrazyme Treatment on Lactation and Infants

This study is currently recruiting participants.
Verified August 2017 by Sanofi ( Genzyme, a Sanofi Company )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00230607
First Posted: October 3, 2005
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
September 29, 2005
October 3, 2005
August 7, 2017
May 28, 2006
December 2019   (Final data collection date for primary outcome measure)
  • Determination of pharmacokinetic parameters of αGAL in breast milk: Cmax [ Time Frame: Month 1, 3, and 6 ]
    Maximum concentration (Cmax) of αGAL in breast milk
  • Determination of pharmacokinetic parameters of αGAL in breast milk: AUC0-2h [ Time Frame: Month 1, 3, and 6 ]
    Area under the plasma αGAL concentration-time curve (AUC) from 0 to 2 hours post end of infusion (AUC0-2)
  • Determination of pharmacokinetic parameters of αGAL in breast milk: lactation clearance [ Time Frame: Month 1, 3, and 6 ]
    Lactation clearance will be estimated as the amount of αGAL excreted over the sampling period divided by the AUC during the sampling period.
  • Volume of breast milk [ Time Frame: Baseline, Month 2, 6, and 12 ]
    Determination of volume of breast milk sample
  • Fat content of breast milk [ Time Frame: Baseline, Months 2, 6, and 12 ]
    Determination of total fat content in breast milk sample
  • Protein content of breast milk [ Time Frame: Baseline, Months 2, 6, and 12 ]
    Determination of total protein content in breast milk sample
  • Growth response of infants [ Time Frame: Months 1, 2, 3, 6, 12, 18 and Month 24 ]
    Absolute change in growth of infants
  • Development response of infants [ Time Frame: Months 1, 2, 3, 6, 12, 18 and Month 24 ]
    Absolute change in weight of infants
  • Immunologic response of infants - IgG [ Time Frame: Baseline, Months 2, 6, and 12 ]
    Formation or presence of immunoglobulin G (IgG) antibodies to recombinant human α galactosidase A (r-hαGAL)
  • Immunologic response of infants - IgM [ Time Frame: Baseline, Months 2, 6, and 12 ]
    Formation or presence of immunoglobulin M (IgM) antibodies to recombinant human α galactosidase A (r-hαGAL)
  • Is a-galactosidase A is present in the breast milk of mothers with Fabry.
  • Determine affects on growth, development, and immunologic response of infants born to mothers with Fabry disease being treated or who have received treatment during their pregnancy with Fabrazyme.
  • Observe the effect of Fabrazyme on lactation.
Complete list of historical versions of study NCT00230607 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
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
The study will last for up to 2 years (24 months). Full participation for both mother and infant is 24 months, full participation of mother and development of infant is 24 months, while full participation of mother and no infant participation is 6 months
NOTE: Estimated Enrollment: 10 mothers and up to 10 infants
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Fabry Disease
  • Alpha Galactosidase A Deficiency
Drug: agalsidase beta
Pharmaceutical form: powder for reconstitution Route of administration: intravenous
Other Names:
  • r-hαGAL
  • Fabrazyme
Experimental: Agalsidase beta
Commercially available Fabrazyme treatment at prescribed dose and regimen as determined by their treating physician
Intervention: Drug: agalsidase beta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
January 2020
December 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Mothers must meet the following criteria to be enrolled in this study:

  • provide signed written informed consent to participate in this study,
  • be enrolled in the Fabry Registry and receiving Fabrazyme while lactating,
  • agree to adhere to the Fabry Registry recommended schedule of assessments for medical history, pregnancy outcome, genotyping, and antibody testing, and
  • agree to adhere to the schedule of evaluations for this study.

Infants must meet the following criteria to be enrolled in this study:

  • have the signed written informed consent of the parent(s)/legal guardian(s) to participate in this study,
  • be born to a mother who is receiving Fabrazyme during lactation,
  • be receiving breast milk from the mother, and
  • have the agreement of the parent(s)/legal guardian(s) to adhere to the schedule of evaluations for this study.

Exclusion Criteria:

  • The mother and infant will be excluded from this study if the mother has received an investigational drug within 30 days prior to study enrollment.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: Medical Information 800-745-4447 medinfo@genzyme.com
Contact: Medical Information 617-252-7832 medinfo@genzyme.com
Austria,   United Kingdom,   United States
 
 
NCT00230607
AGAL02603
2006-001910-33 ( EudraCT Number )
MSC12868 ( Other Identifier: Sanofi )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com
Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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