Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease

ClinicalTrials.gov ID: NCT00364858

Public ClinicalTrials.gov record NCT00364858. 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.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 10:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase IV, Multicenter, Randomized, Dose Frequency Study of the Safety and Efficacy of Cerezyme® Infusions Every Four Weeks Versus Every Two Weeks in the Maintenance Therapy of Patients With Type 1 Gaucher Disease

Brief summary

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

This is a multicenter, randomized trial to compare the safety and efficacy of two dosing frequencies of Cerezyme® in patients with Gaucher disease who are currently being treated with Cerezyme®. Approximately 90 patients will be randomized in a 2:1 (q4 : q2) ratio to one of two treatment arms at up to 26 study centers worldwide. Patients will continue to receive the same total 4-week dose that they were receiving prior to study enrollment, however, they will be randomized to receive either their total 4-week dose in two infusions, one infusion every 2 weeks or their total 4-week dose in one infusion every 4 weeks. The randomization scheme will ensure a 2:1 balance between the every 4-week versus every 2-week infusion groups, respectively.

Study identification

NCT ID: NCT00364858
Recruitment status: Completed
Study type: Interventional
Phase: Phase 4
Lead sponsor: Genzyme, a Sanofi Company; Industry
Enrollment: 95 participants

Conditions and interventions

Conditions

Interventions

Cerezyme Drug

Drug

Eligibility (public fields only)

Age range: 18 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: Nov 30, 2001
Primary completion: Not listed
Completion: Jan 31, 2007
Last update posted: Apr 2, 2015

2001 – 2007

United States locations

U.S. sites: 18
U.S. states: 12
U.S. cities: 17

Facility	City	State	ZIP	Site status
Children's National Medical Center	Washington D.C.	District of Columbia	20010	—
University Research Foundation for Lysosomal Storage Disease, Inc.	Coral Springs	Florida	33065	—
Emory University	Atlanta	Georgia	30322	—
Children's Memorial Hospital	Chicago	Illinois	60614	—
Midwest Cancer Research Group, Inc.	Skokie	Illinois	60076	—
Massachusetts General Hospital	Boston	Massachusetts	02114	—
Institute for Genetics Medicine Saint Peter's University Hospital	New Brunswick	New Jersey	08903	—
Holy Name Hospital	Teaneck	New Jersey	07666	—
Hemophilia Center of Western New York	Buffalo	New York	14215	—
New York Oncology/Hematology PC	Latham	New York	12110	—
New York University	New York	New York	10016	—
Mt. Sinai Medical Center	New York	New York	10029	—
Duke University Medical Center	Durham	North Carolina	27710	—
Children's Hospital Research Foundation	Cincinnati	Ohio	45229	—
Oregon Health & Science University	Portland	Oregon	97239	—
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	—
University of Pittsburgh	Pittsburgh	Pennsylvania	15261	—
University of Utah	Salt Lake City	Utah	84132	—

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 8 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00364858, 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 Apr 2, 2015 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00364858 live on ClinicalTrials.gov.

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