NCT00566878Completed
Pompe Lactation Sub-Registry
A Sub-Registry to Determine the Presence of Alglucosidase Alfa in Breast Milk From Women With Pompe Disease Treated With Alglucosidase Alfa.
Source: ClinicalTrials.gov · Last updated 19 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2 (actual)
- First submitted
- 1 Dec 2007
- Start date
- 31 Mar 2012
- Primary completion date
- 9 Feb 2024
- Lead sponsor
- Genzyme, a Sanofi Company
- Diseases
- Pompe disease
- NCT number
- NCT00566878
What you commit to
- Study type: Observational
- Participants enrolled: 2
- From 31 Mar 2012 to the primary completion date, 9 Feb 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Registry participation is worldwide. Facilities not yet active may enroll upon identification of a patient Coordinator of this site? Confirm its status | Cambridge | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.