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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 April 2024 |
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Main ID: |
NCT00567073 |
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Date of registration:
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01/12/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pompe Pregnancy Sub-Registry
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Scientific title:
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A Sub-registry to Observe the Effect of Alglucosidase Alfa or Avalglucosidase Alfa Treatment on Pregnancy and Infant Growth in Women With Pompe Disease |
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Date of first enrolment:
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June 18, 2007 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT00567073 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Belgium
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Croatia
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Czechia
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Italy
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United States
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Contacts
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Name:
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Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genzyme, a Sanofi Company |
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Name:
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Trial Transparency email recommended (Toll free number for US & Canada) |
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Address:
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Telephone:
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800-633-1610 |
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Email:
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Contact-Us@sanofi.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Eligible women must:
- be enrolled in the Pompe registry (NCT00231400)
- be pregnant, or have been pregnant with appropriate medical documentation available.
- provide a signed informed consent and authorization form(s) to participate in the
Sub-Registry prior to any Sub-Registry-related data collection being performed.
Note: It is recommended that pregnancy data be collected on eligible women regardless of
infant enrollment. In the event of patients having multiple pregnancies, participation in
this Sub-Registry is encouraged for each individual pregnancy.
Exclusion Criteria:
There are no exclusion criteria for this Sub-Registry
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pompe Disease (Late-onset)
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Glycogen Storage Disease Type II (GSD-II)
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Glycogenesis 2 Acid Maltase Deficiency
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Primary Outcome(s)
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Follow-up of infants born to women with Pompe disease for 3 years post-partum
[Time Frame: 3 years]
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Pregnancy outcomes, including complications and infant growth, in all women with Pompe disease during pregnancy, regardless of whether they receive disease-specific therapy such as ERT with alglucosidase alfa or avalglucosidase alfa
[Time Frame: 10 Months]
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Secondary ID(s)
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AGLU03506
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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