Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Pompe Pregnancy Sub-Registry
Pompe Pregnancy Sub-Registry

NCT00567073

RecruitingN/A

Sponsor: Genzyme, a Sanofi Company

Conditions: Glycogen Storage Disease Type II (GSD-II), Pompe Disease (Late-onset), Glycogenesis 2 Acid Maltase Deficiency

Countries: United States, Australia, Belgium, Brazil, Croatia, Czechia, Germany, Italy

This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Pompe Registry, regardless of whether she is receiving disease-specific therapy (such as ERT with alglucosidase alfa or avalglucosidase alfa) and irrespective of the commercial product with which she may be treated. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. The primary objective of this Sub-registry is to track 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.

Eligibility overview

Sex: FEMALE

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (35)
  • Phoenix, Arizona, United States
  • Jacksonville, Florida, United States
  • Atlanta, Georgia, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Grand Rapids, Michigan, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Dublin, Ohio, United States
  • Portland, Oregon, United States
  • Greenville, South Carolina, United States
  • Fairfax, Virginia, United States
  • Westmead, New South Wales, Australia
  • Ghent, Belgium
  • São Paulo, Brazil
  • Zagreb, Croatia
  • Zagreb, Croatia
  • Prague, Czechia
  • Bonn, Germany
  • Florence, Firenze, Italy
  • Milan, Milano, Italy
  • Padua, Padova, Italy
  • Rome, Roma, Italy
  • Brescia, Italy
  • Cagliari, Italy
  • Genova, Italy
  • Messina, Italy
  • + 5 more on CT.gov