RECRUITING

Pompe Pregnancy Sub-Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Sub-registry to Observe the Effect of Alglucosidase Alfa or Avalglucosidase Alfa Treatment on Pregnancy and Infant Growth in Women With Pompe Disease

Quick Facts

Study Start:2007-06-18
Study Completion:2034-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00567073

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * be enrolled in the Pompe registry (NCT00231400)
  2. * be pregnant, or have been pregnant with appropriate medical documentation available.
  3. * 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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free number for US & Canada)
CONTACT
800-633-1610
Contact-Us@sanofi.com
Pompe Registry HelpLine
CONTACT
617-591-5500

Principal Investigator

Study Director
STUDY_DIRECTOR
Genzyme, a Sanofi Company

Study Locations (Sites)

Barrow Neurol Group- Site Number : 840087
Phoenix, Arizona, 85013
United States
Emory University School Of Medicine- Site Number : 840060
Atlanta, Georgia, 30322
United States
Indianapolis University School of Medicine- Site Number : 840027
Indianapolis, Indiana, 46202
United States
Spectrum for Health- Site Number : 840019
Grand Rapids, Michigan, 49503
United States
New York University School Of Medicine- Site Number : 840040
New York, New York, 10016
United States
Mt. Sinai School of Medicine- Site Number : 840005
New York, New York, 10029
United States
Duke University Medical Center Genetics Dept- Site Number : 840037
Durham, North Carolina, 27710
United States
LSD Data Registry Site LLC- Site Number : 840094
Dublin, Ohio, 43017
United States
Oregon Health and Science University- Site Number : 840095
Portland, Oregon, 97239
United States
O&O Alpan, LLC- Site Number : 840025
Fairfax, Virginia, 22030
United States

Collaborators and Investigators

Sponsor: Genzyme, a Sanofi Company

  • Study Director, STUDY_DIRECTOR, Genzyme, a Sanofi Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2007-06-18
Study Completion Date2034-01-31

Study Record Updates

Study Start Date2007-06-18
Study Completion Date2034-01-31

Terms related to this study

Keywords Provided by Researchers

  • Glycogen Storage Disease Type II (GSD-II)
  • GSD-II
  • Pompe Disease
  • Pompe Disease (Late-Onset)
  • Acid Maltase Deficiency Disease
  • Glycogenosis II

Additional Relevant MeSH Terms

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