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New study monitors pregnancy in pompe disease patients

NCT ID NCT00567073

Knowledge-focused Sponsor: Genzyme, a Sanofi Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows pregnant women with Pompe disease to see how the condition and its treatments affect pregnancy and infant growth. Researchers will track complications and monitor babies for up to three years after birth. No new drugs are being tested; participants receive their usual care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could provide crucial safety data to guide treatment decisions for pregnant women with Pompe disease.
What could go wrong
This is an observational registry with only 20 participants, so findings may not apply to all patients. No new treatment is being tested.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2007

Expected to finish

Jan 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant Females with Pompe disease and/or infants born to females with Pompe disease. Participants may or may not be receiving therapy

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

glycogen storage disease due to acid maltase deficiency, late-onset glycogen storage disease II Glycogen Storage Disease Type II

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glycogen storage disease type II (GSD-ii) Glycogenesis 2 acid maltase deficiency Pompe disease (late-onset)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    34 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Barrow Neurol Group- Site Number : 840087

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • Columbia University Irving Medical Center- Site Number : 157199

    RECRUITING

    New York, New York, 10032, United States

  • Duke University Medical Center Genetics Dept- Site Number : 840037

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University School Of Medicine- Site Number : 840060

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Greenwood Genetic Center - Greenville- Site Number : 151184

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Indianapolis University School of Medicine- Site Number : 840027

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Instituto de Genética e Erros Inatos do Metabolismo- Site Number : 150978

    RECRUITING

    São Paulo, 04020-041, Brazil

  • Investigational Site Number : 056001

    RECRUITING

    Ghent, 9000, Belgium

  • Investigational Site Number : 151069

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Investigational Site Number : 152200

    RECRUITING

    Bonn, 53127, Germany

  • Investigational Site Number : 1910001

    RECRUITING

    Zagreb, 10000, Croatia

  • Investigational Site Number : 1910002

    RECRUITING

    Zagreb, 10000, Croatia

  • Investigational Site Number : 2030001

    RECRUITING

    Prague, 128 08, Czechia

  • Investigational Site Number : 380002

    RECRUITING

    Padova, 35128, Italy

  • Investigational Site Number : 380003

    RECRUITING

    Pavia, 27100, Italy

  • Investigational Site Number : 380004

    RECRUITING

    Genova, 16147, Italy

  • Investigational Site Number : 380005

    RECRUITING

    Florence, Firenze, 50139, Italy

  • Investigational Site Number : 380006

    RECRUITING

    Cagliari, 09126, Italy

  • Investigational Site Number : 380007

    RECRUITING

    Milan, Milano, 20133, Italy

  • Investigational Site Number : 380008

    RECRUITING

    Brescia, 25123, Italy

  • Investigational Site Number : 380009

    RECRUITING

    Monza, Italy

  • Investigational Site Number : 380011

    RECRUITING

    Padua, Padova, 35128, Italy

  • Investigational Site Number : 380012

    RECRUITING

    Roma, Italy

  • Investigational Site Number : 380013

    RECRUITING

    Messina, 98125, Italy

  • Investigational Site Number : 380015

    RECRUITING

    Rome, Roma, 00165, Italy

  • Investigational Site Number : 87147

    RECRUITING

    Cardiff, Cardiff [Caerdydd Gb-crd], CF14 4XW, United Kingdom

  • LSD Data Registry Site LLC- Site Number : 840094

    RECRUITING

    Dublin, Ohio, 43017, United States

  • Mt. Sinai School of Medicine- Site Number : 840005

    RECRUITING

    New York, New York, 10029, United States

  • New York University School Of Medicine- Site Number : 840040

    RECRUITING

    New York, New York, 10016, United States

  • O & O Alpan- Site Number : 840025

    RECRUITING

    Fairfax, Virginia, 22030, United States

  • Oregon Health and Science University- Site Number : 840095

    COMPLETED

    Portland, Oregon, 97239, United States

  • Spectrum for Health- Site Number : 840019

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • University of Florida Pediatrics Genetics- Site Number : 157138

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • University of Iowa- Site Number : 150294

    RECRUITING

    Iowa City, Iowa, 52242-1009, United States

  • Washington University- Site Number : 150612

    RECRUITING

    St Louis, Missouri, 63110, United States

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