DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Study of the Effects of Fabrazyme (Agalsidase Beta) on Mother's Lactation and on the Growth, Development and Immunologic Response of Their Infants

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fabry Disease

Intervention: agalsidase beta (Biological)

Phase: Phase 4

Status: Recruiting

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

Overall contact:
Medical Information, Phone: 800-745-4447, Email: medinfo@genzyme.com

Summary

The purpose of this study is to observe the potential effects of Fabrazyme (agalsidase beta) treatment on lactation and on the growth, development, and immunologic response of infants born to mothers with Fabry disease who are treated with Fabrazyme during lactation. There are 3 participation scenarios: mother/infant full participation, mother full participation/infant development assessment only, and mother full participation/infant no participation. Whether or not the mother continues to lactate will be assessed at each visit. If the mother is no longer lactating, the mother will discontinue this study but continue to be followed in the Fabry Registry. The infant (if participating) will be followed for development only for the remainder of this 24 month study.

Clinical Details

Official title: A Multicenter, Multinational Study of the Effects of Fabrazyme (Agalsidase Beta) Treatment on Lactation and Infants

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Presence of alpha-galactosidase (αGAL) activity in breast milk of mothers who are being treated with Fabrazyme (agalsidase beta) during lactation

Growth and development of infants born to mothers who have received Fabrazyme (agalsidase beta) treatment during lactation

Volume, total fat and protein content in breast milk of mothers who are being treated with Fabrazyme (agalsidase beta) during lactation

Pharmacokinetics: Milk αGAL to plasma αGAL ratio

Formation or continued presence of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to α-galactosidase A (r-hαGAL) in infants receiving breast milk from mothers treated with Fabrazyme (agalsidase beta) during lactation

Detailed description: NOTE: Estimated Enrollment: 10 mothers and up to 10 infants

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Mother must provide signed written informed consent to participate in this study.

- Mother must be enrolled in the Fabry Registry and receiving Fabrazyme (agalsidase

beta) while lactating.

- Mother must agree to adhere to the Fabry Registry recommended schedule of assessments

for medical history, pregnancy outcome, genotyping, and antibody testing.

- Mother must agree to adhere to the schedule of evaluations for this study.

- Infant must have the signed written informed consent of the parent(s)/legal

guardian(s) to participate in this study.

- Infant must be born to a mother who is receiving Fabrazyme (agalsidase beta) during

lactation.

- Infant must be receiving breast milk from the mother.

- Infant must 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.

Locations and Contacts

Medical Information, Phone: 800-745-4447, Email: medinfo@genzyme.com

Salzburg, Austria; Completed

Salford, United Kingdom; Completed

Participation in this study is not limited to this facility; facilities not yet active may enroll upon identification of a patient, Cambridge, Massachusetts, United States; Recruiting

Dallas, Texas, United States; Terminated

Milwaukee, Wisconsin, United States; Completed

Additional Information

Starting date: August 2006
Last updated: April 7, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017