NotablePrimary and study completion dates: Jan 31, 2030 to Jan 31, 2034
Study sites: 63 to 221
v23
MinorPublications: 6 to 8v22
MinorPrimary and study completion dates: Jan 2030 to Jan 31, 2030v21
MinorStudy sites: 1 to 63v20
2 versionsRe-verified since Aug 26, 2014, no change to tracked fieldsv18-v19
MinorStudy description shortened, about 47 wordsv17
Re-verified, no change to tracked fieldsv16
MinorEnrollment target: 12000
Primary and study completion dates: Jan 2030
v15
MinorStudy description shortened, about 1 wordv14
4 versionsRe-verified since Jul 30, 2009, no change to tracked fieldsv10-v13
MinorEnrollment target: 99999 to not statedv9
MinorEnrollment target: 99999v8
Re-verified, no change to tracked fieldsv7
Study Status, Study Design, Eligibilityv6
MinorEligibility criteria expanded, about 1 word
Study description expanded, about 1 word
Study title expanded, about 2 words
v5
MinorStart date: Nov 2001 to Apr 1991v4
MinorStudy description revisedv3
MinorStudy description shortened, about 290 words
Study site revised
v2
Study First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.