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NCT00358943 · ClinicalTrials.gov registry record
International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry
A clinical trial of Gaucher Disease and Cerebroside Lipidosis Syndrome, sponsored by Genzyme, a Sanofi Company.
- Recruiting
- Registry status
- 12,000
- Enrollment target
- 20
- Study locations
NCT00358943: Recruiting study of Gaucher Disease and Cerebroside Lipidosis Syndrome, sponsored by Genzyme, a Sanofi Company.
NCT00358943 is a study of Gaucher Disease and Cerebroside Lipidosis Syndrome that is actively recruiting participants, run by Genzyme, a Sanofi Company. The registered enrollment target is 12,000 participants, above the 136-participant average among 13 other Gaucher Disease trials with a reported enrollment target (8724% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00358943, a study of Gaucher Disease and Cerebroside Lipidosis Syndrome, is actively recruiting participants, sponsored by Genzyme, a Sanofi Company.
- RECRUITING
- Registry status
- 12,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The objectives of the Registry are: * To enhance understanding of the variability, progression, identification, and natural history of Gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention. * To assist the Gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. * To characterize the Gaucher disease population. * To evaluate the long-term effectiveness of imiglucerase and of eliglustat. Gaucher Pregnancy Sub-registry: The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.
Conditions Studied
Study Locations (20)
California
- Tower Hematology/Oncology Medical Group- Site Number : 840056 - Beverly Hills
- University of California at Irvine- Site Number : 840036 - Irvine
- 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 of Orange County- Site Number : 840074 - Orange
- Stanford Unviersity MC Dept of Genetics- Site Number : 840022 - Palo Alto
- UC Davis MIND Institute- Site Number : 840010 - Sacramento
- Kaiser Permanente Hospital- Site Number : 840042 - Sacramento
- University of California at San Diego- Site Number : 840007 - San Diego
- University of California at San Francisco- Site Number : 840051 - San Francisco
Florida
- University Hematology Oncology- Site Number : 840075 - Coral Springs
- University of Florida Pediatrics Genetics- Site Number : 840121 - Jacksonville
- The Atwal Clinic- Site Number : 840112 - Jacksonville
- University Of Miami SOM- Site Number : 840006 - Miami
Arizona
- 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
Connecticut
- Yale - Site Number : 840047 - New Haven
District of Columbia
- Children's National Medical Center- Site Number : 840067 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12,000 participants |
| Start Date | 1991-04-01 |
| Est. Completion | 2034-01-31 |
What NCT00358943 shows while recruiting
NCT00358943 is an observational study that tracks outcomes without assigning an intervention. Its 12,000 participants enrollment target places it among the larger protocols in the corpus, above the 136-participant average among 13 other Gaucher Disease trials with a reported enrollment target (8724% higher).
The record links to 4 conditions, with Gaucher Disease appearing as the primary indexed condition, and to 0 interventions.
NCT00358943 names 20 study sites across 6 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT00358943 about?
NCT00358943 is a clinical study titled "International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry". The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical asses...
What is the current status of trial NCT00358943?
This trial is currently recruiting. The enrollment target is 12,000 participants. The study started on 1991-04-01. Estimated completion is 2034-01-31.
What conditions does trial NCT00358943 study?
This clinical trial studies the following conditions: Gaucher Disease, Cerebroside Lipidosis Syndrome, Glucocerebrosidase Deficiency Disease, Glucosylceramide Beta-Glucosidase Deficiency Disease.
Who is sponsoring clinical trial NCT00358943?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00358943 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00358943's enrollment target sits among peer trials
12,000 1st of 13 higher than 13 of 13 other Gaucher Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gaucher Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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