Fabry Hastalığı Kayıt Sistemi ve Gebelik Alt-Kayıt Sistemi

Sade dilde özet

Bu çalışma, Fabry Hastalığı (Fabry disease) olan hastaların izlendiği bir kayıt sistemidir; ayrıca bir gebelik alt-kayıt sistemi bulunur. Plazma/lökosit αGAL (alfa-galaktozidaz) enzim eksikliği ve/veya gen mutasyonu ile tanısı doğrulanmış tüm hastalar dahil edilir. Faz uygulanmayan gözlemsel bir kayıttır; şu anda katılımcı almaktadır (recruiting).

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Katılımcı alıyor

Sponsor

Genzyme, a Sanofi Company

Başlangıç

31.07.2001

Tahmini bitiş

31.01.2034

Ülkeler

United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Italy, Japan, Lithuania, Malaysia, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom, Vietnam

İlgili genler

Merkezler

• Birmingham, United States
• Birmingham, United States
• Phoenix, United States
• Tucson, United States
• Little Rock, United States
• Little Rock, United States
• Irvine, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Oakland, United States
• Orange, United States
• Sacramento, United States
• Sacramento, United States
• San Diego, United States
• San Francisco, United States
• Stanford, United States
• New Haven, United States
• Washington D.C., United States
• Coral Gables, United States
• Coral Springs, United States
• Gainesville, United States
• Jacksonville, United States
• Tampa, United States
• Decatur, United States
• Aurora, United States
• Chicago, United States
• Chicago, United States
• Indianapolis, United States
• Iowa City, United States
• Kansas City, United States
• Louisville, United States
• Baton Rouge, United States
• New Orleans, United States
• Portland, United States
• Baltimore, United States
• Boston, United States
• Boston, United States
• Boston, United States
• Springfield, United States

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Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria

* Fabry Registry: All patients with a confirmed diagnosis of Fabry disease who have signed the informed consent and patient authorization form(s) are eligible for inclusion. Confirmed diagnosis is defined as a documented deficiency in plasma or leukocyte αGAL (alpha-galactosidase) enzyme activity and/or mutation(s) in the gene coding for αGAL.
* Fabry Pregnancy Sub-registry:

  * Eligible women must:

    * be enrolled in the Fabry Registry.
    * be pregnant, or have been pregnant with appropriate medical documentation available.
    * provide a signed informed consent and authorization form(s) to participate in the Sub-Registry prior to any Sub-Registry-related data collection being performed.

Exclusion Criteria Fabry Registry: There are no exclusion criteria. Fabry Pregnancy Sub-registry: There are no exclusion criteria.