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NCT02152189 Clinical Trial

Screening for Fabry Disease in a Pediatric Population at Risk

Fabry Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02152189
Other study ID # Fabry screening 02202014
Secondary ID S-084/2014
Status Completed
Phase N/A
First received May 22, 2014
Last updated December 11, 2017
Start date May 2014
Est. completion date November 2017

Study information
Verified date December 2017
Source University Hospital Heidelberg
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the frequency of Fabry disease in children with chronic abdominal pain or chronic pain in the extremities

Recruitment information / eligibility
Status Completed
Enrollment 1422
Est. completion date November 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- Age below 18 years

- One of the following criteria:

- Diagnosis or suspicion of a rheumatological disorder with recurrent complaints for more than 6 months

- Chronic, recurrent abdominal pain for more than 6 months

- Planned blood sample for routine diagnostics

- Written informed consent

Exclusion Criteria:

- Patient and/or the patient's parent(s) or legal guardian(s) are unable to understand the nature, scope, and possible consequences of the screening.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Screening for Fabry disease

Locations
Country Name City State
Germany Zentrum für Kinder- und Jugendmedizin Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Ries M, Gupta S, Moore DF, Sachdev V, Quirk JM, Murray GJ, Rosing DR, Robinson C, Schaefer E, Gal A, Dambrosia JM, Garman SC, Brady RO, Schiffmann R. Pediatric Fabry disease. Pediatrics. 2005 Mar;115(3):e344-55. Epub 2005 Feb 15. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of Fabry disease day 1
Secondary Prevalence of Fabry disease in predefined sub-populations day 1
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