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Completed Phase 3 Interventional Results available

An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher Disease

ClinicalTrials.gov ID: NCT00635427

Public ClinicalTrials.gov record NCT00635427. 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.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 10:27 AM EDT

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 Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients With Type 1 Gaucher Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the long-term safety of every other week dosing of Gene-Activated® human glucocerebrosidase (GA-GCB, velaglucerase alfa) intravenously in patients with type 1 Gaucher disease.

Study identification

NCT ID
NCT00635427
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
95 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
2 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 13, 2008 (Actual)
Primary completion
Dec 28, 2012 (Actual)
Completion
Dec 28, 2012 (Actual)
Last update posted
Jun 10, 2021

2008 – 2012

United States locations

U.S. sites
10
U.S. states
9
U.S. cities
10
Facility City State ZIP Site status
Los Angeles Medical Center Los Angeles California 90027 —
Children's Hospital Oakland Oakland California 94609 —
Emory University School of Medicine Atlanta Georgia 30322 —
Children's Memorial Hospital Chicago Illinois 60614 —
Children's Hospitals and Clinics of Minnesota Minneapolis Minnesota 55404 —
Children's Mercy Hospitals & Clinics Kansas City Missouri 64108 —
NYU Medical Center New York New York 10016 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
University of Utah Medical Center Salt Lake City Utah 84132 —
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226 —

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 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00635427, 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 Jun 10, 2021 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00635427 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →