Late-Onset Treatment Study Extension Protocol
Public ClinicalTrials.gov record NCT00455195. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label Extension Study of Patients With Late-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU02704
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The objective of this extension study is to assess the long-term safety and efficacy of alglucosidase alfa treatment in patients with Late-Onset Pompe Disease who were previously treated under the placebo-controlled, double-blind study AGLU02704 (NCT00158600).
Study identification
- NCT ID
- NCT00455195
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 81 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 8 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2007 (Type not available)
- Primary completion
- Oct 2008 (Actual)
- Completion
- Nov 2008 (Actual)
- Last update posted
- Mar 7, 2014
2007 – 2008
United States locations
- U.S. sites
- 26
- U.S. states
- 20
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Anchorage | Alaska | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Beverly Hills | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Washington D.C. | District of Columbia | — | — |
| Not listed | Coral Springs | Florida | — | — |
| Not listed | Gainesville | Florida | — | — |
| Not listed | Sarasota | Florida | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Kansas City | Kansas | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Omaha | Nebraska | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Durham | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Toledo | Ohio | — | — |
| Not listed | Tulsa | Oklahoma | — | — |
| Not listed | Portland | Oregon | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Greenville | South Carolina | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Seattle | Washington | — | — |
| Not listed | Green Bay | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00455195, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 7, 2014 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00455195 live on ClinicalTrials.gov.