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NCT00231400 · ClinicalTrials.gov registry record

Pompe Disease Registry Protocol

A clinical trial of Pompe Disease and Glycogen Storage Disease Type II, sponsored by Genzyme, a Sanofi Company.

Recruiting
Registry status
2,000
Enrollment target
20
Study locations

NCT00231400 is a study of Pompe Disease and Glycogen Storage Disease Type II that is actively recruiting participants, run by Genzyme, a Sanofi Company. The registered enrollment target is 2,000 participants, above the 90-participant average among 14 other Pompe Disease trials with a reported enrollment target (2122% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT00231400, a study of Pompe Disease and Glycogen Storage Disease Type II, is actively recruiting participants, sponsored by Genzyme, a Sanofi Company.

RECRUITING
Registry status
2,000 participants
Enrollment target
20
Study locations

Study Summary

The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. Data from the Registry are also used to fulfill various global regulatory commitments, to support product development/reimbursement, and for other research and non-research related purposes. The objectives of the Registry are: * To enhance understanding of the variability, progression, identification, and natural history of Pompe disease, with the ultimate goal of better guiding and assessing therapeutic intervention. * To assist the Pompe medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. * To characterize the Pompe disease population. * To evaluate the long-term effectiveness of alglucosidase alfa.

Study Locations (20)

California

  • University of California at Irvine- Site Number : 840036 - Irvine
  • Loma Linda University- Genetics- Site Number : 840070 - Loma Linda
  • Southern California Permanente Medical Group- Site Number : 840108 - Los Angeles
  • USC Health Sciences Center Dept of Genetics- Site Number : 840082 - Los Angeles
  • Children's Hospital Oakland- Site Number : 840029 - Oakland
  • Children's Hospital of Orange County- Site Number : 840074 - Orange
  • UC Davis MIND Institute- Site Number : 840010 - Sacramento
  • University of California at San Diego- Site Number : 840007 - San Diego
  • University of California at San Francisco- Site Number : 840051 - San Francisco
  • Stanford University Pediatrics- Site Number : 840021 - Stanford

Arizona

  • Barrow Neurological Institute- Site Number : 840087 - Phoenix
  • Phoenix Children's Hospital- Site Number : 840003 - Phoenix
  • University of Arizona- Site Number : 840015 - Tucson

Arkansas

  • Arkansas Childrens Hospital- Site Number : 840109 - Little Rock
  • University of Arkansas for Medical Sciences- Site Number : 840113 - Little Rock

Alabama

  • University Alabama at Birmingham- Site Number : 840106 - Birmingham

Colorado

  • Children's Hospital Colorado - Aurora- Site Number : 840069 - Aurora

Connecticut

  • Yale - Site Number : 840047 - New Haven

District of Columbia

  • Children's National Medical Center- Site Number : 840067 - Washington D.C.

Florida

  • University of Florida College of Medicine- Site Number : 840012 - Gainesville

Trial Details

FieldValue
Enrollment Target 2,000 participants
Start Date 2004-09-15
Est. Completion 2034-01-31

Sponsor

Genzyme, a Sanofi Company

196 total trials

What the Registry Record Tells You About NCT00231400

The ClinicalTrials.gov registry entry for NCT00231400 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 90-participant average among 14 other Pompe Disease trials with a reported enrollment target (2122% higher). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Pompe Disease appearing as the primary indexed condition, and to 0 interventions.

NCT00231400 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT00231400 about?

NCT00231400 is a clinical study titled "Pompe Disease Registry Protocol". The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. Data from the Registry are also used to fulfill various glob...

What is the current status of trial NCT00231400?

This trial is currently recruiting. The enrollment target is 2,000 participants. The study started on 2004-09-15. Estimated completion is 2034-01-31.

What conditions does trial NCT00231400 study?

This clinical trial studies the following conditions: Pompe Disease, Glycogen Storage Disease Type II.

Who is sponsoring clinical trial NCT00231400?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00231400 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.