Pompe Lactation Sub-Registry

NCT ID: NCT00566878

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2024-02-09

Brief Summary

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The objective is to determine if alglucosidase alfa is present in breast milk from mothers with Pompe Disease being treated with alglucosidase alfa and to measure breast milk production and composition in women with Pompe Disease who receive alglucosidase alfa.

Detailed Description

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Conditions

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Glycogen Storage Disease Pompe Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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alglucosidase alfa

At least one infusion of alglucosidase alfa post partum

Intervention Type BIOLOGICAL

Other Intervention Names

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Myozyme Lumizyme

Eligibility Criteria

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Inclusion Criteria

* Must be enrolled in Pompe Registry (NCT00231400)
* Must be pregnant and intend to breast-feed or be currently lactating and receive at least one infusion of alglucosidase alfa while lactating
* Provide a signed Patient Information and Authorization form to participate in the sub-registry prior to any sub-registry-related assessments are performed
* Agree to adhere to the sub-registry guidelines for antibody testing and recommended schedule of assessments.

Exclusion Criteria

* Patients will be excluded from this sub-registry if they have received an investigational drug (excluding alglucosidase alfa in regions where alglucosidase alfa is not commercially available) within 30 days prior to Visit 1 breast milk collection
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Locations

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Registry participation is worldwide. Facilities not yet active may enroll upon identification of a patient

Cambridge, Massachusetts, United States

Site Status

Grand Rapids, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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LTS13972

Identifier Type: OTHER

Identifier Source: secondary_id

AGLU03406

Identifier Type: -

Identifier Source: org_study_id

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