Clinical Relevance of Typing HLA-DR7-DQ2

Celiac Disease Patients Following Recommendations of ESPGHAN Clinical Trial

— HLA  

Official title:

Clinical Relevance of Typing HLA-DR7-DQ2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813383
• Other study ID #: Celiac disease and HLA-DQ2.2
• Status: Completed
• Phase: N/A
• First received: March 12, 2013
• Last updated: March 14, 2013
• Start date: January 2010
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial Summary

Celiac disease patients with HLA-DR7-DQ2 haplotype have the same histological, analytical and clinical behaviour as patients with HLA-DR3-DQ2 haplotype.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosis of celiac disease following ESPGHAN recommendations

• HLA-DQ2 typing including HLA-DR3-DQ2 and HLA-DR7-DQ2 haplotypes

Exclusion Criteria:

• Patients who have not been diagnosed for celiac disease

• HLA-DQ2 typing that not include HLA-DR7-DQ2 haplotype

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Celiac Disease
• Celiac Disease Patients Following Recommendations of ESPGHAN
• HLA-DQ2 Typing Include HLA-DR7-DQ2 Haplotypes

Intervention

Other:
• There is not any intervention

Locations

Country	Name	City	State
Spain	Corporació Sanitària i Universitària Parc Taulí	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oberhuber histological damage classification		Up to 1 month after diagnosis	Yes
Other	Clinical characteristics of celiac disease	Asymptomatic, intestinal symptoms, extra-intestinal symptoms, European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) score	Up to 1 month after diagnosis	Yes
Primary	Anti-tissue transglutaminase		Up to 1 month after diagnosis	Yes
Secondary	Anti-Endomysium autoantibodies		Up to 1 month after diagnosis	Yes