Celiac Disease Patients Following Recommendations of ESPGHANHLANCT01813383
Clinical Relevance of Typing HLA-DR7-DQ2
An observational study of Celiac Disease Patients Following Recommendations of ESPGHAN and HLA-DQ2 Typing Include HLA-DR7-DQ2 Haplotypes, run by Corporacion Parc Tauli at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Celiac Disease Patients Following Recommendations of ESPGHAN, HLA-DQ2 Typing Include HLA-DR7-DQ2 Haplotypes
- What is being tested?
- There is not any intervention
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Celiac disease patients who have been diagnosed in a Hospital by a Pediatrician.
Who may be able to join
- Diagnosis of celiac disease following ESPGHAN recommendations
- HLA-DQ2 typing including HLA-DR3-DQ2 and HLA-DR7-DQ2 haplotypes
Who cannot join
- Patients who have not been diagnosed for celiac disease
- HLA-DQ2 typing that not include HLA-DR7-DQ2 haplotype
Trial locations and contacts
1 site in 1 country.
Spain1 site
Corporació Sanitària i Universitària Parc Taulí
Sabadell, Barcelona, 08208
About this study
Celiac disease patients with HLA-DR7-DQ2 haplotype have the same histological, analytical and clinical behaviour as patients with HLA-DR3-DQ2 haplotype.
- Conditions
- Celiac Disease Patients Following Recommendations of ESPGHAN, HLA-DQ2 Typing Include HLA-DR7-DQ2 Haplotypes
- Being tested
- There is not any intervention
- Keywords
- Celiac disease, HLA-DQ2.2, HLA-DQ2.5, HLA-DR7-DQ2, HLA-DR3-DQ2
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is not any interventionOther
| Study group | Role | What they receive |
|---|---|---|
| HLA-DR3-DQ2 patients | Patients with HLA-DR3-DQ2 haplotype Receives: Other: There is not any intervention | |
| HLA-DR7-DQ2 patients | Patients with HLA-DR7-DQ2 haplotype Receives: Other: There is not any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-tissue transglutaminase
Measured: Up to 1 month after diagnosis
Secondary outcomes (1)
Anti-Endomysium autoantibodies
Measured: Up to 1 month after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease Patients Following Recommendations of ESPGHANStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Francisco Delgado de la Poza, Corporacion Parc Tauli
- Investigators
- Juan Francisco Delgado de la Poza, Principal investigator, Immunology Section, Laboratori. UDIAT-CD. Corporació Sanitària i Universitària Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813383
- Sponsor's protocol ID
- Celiac disease and HLA-DQ2.2
- Acronym
- HLA
- Status last verified
- Mar 2013
- First submitted
- 12 Mar 2013
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Relevance of Typing HLA-DR7-DQ2
- ClinicalTrials.gov ID
- NCT01813383
- Acronym / sponsor ID
- HLA / Celiac disease and HLA-DQ2.2
- Conditions
- Celiac Disease Patients Following Recommendations of ESPGHAN, HLA-DQ2 Typing Include HLA-DR7-DQ2 Haplotypes
- Keywords
- Celiac disease, HLA-DQ2.2, HLA-DQ2.5, HLA-DR7-DQ2, HLA-DR3-DQ2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Celiac disease patients with HLA-DR7-DQ2 haplotype have the same histological, analytical and clinical behaviour as patients with HLA-DR3-DQ2 haplotype.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLA-DR3-DQ2 patients | – | Other: There is not any interventionPatients with HLA-DR3-DQ2 haplotype |
| HLA-DR7-DQ2 patients | – | Other: There is not any interventionPatients with HLA-DR7-DQ2 haplotype |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Celiac disease patients who have been diagnosed in a Hospital by a Pediatrician.
Key inclusion criteria (2 listed)
- Diagnosis of celiac disease following ESPGHAN recommendations
- HLA-DQ2 typing including HLA-DR3-DQ2 and HLA-DR7-DQ2 haplotypes
Key exclusion criteria (2 listed)
- Patients who have not been diagnosed for celiac disease
- HLA-DQ2 typing that not include HLA-DR7-DQ2 haplotype
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is not any intervention | Other | HLA-DR3-DQ2 patients, HLA-DR7-DQ2 patients |
Primary outcome
Anti-tissue transglutaminase
Time frame: Up to 1 month after diagnosis
1 secondary outcome
Anti-Endomysium autoantibodies
Time frame: Up to 1 month after diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Francisco Delgado de la Poza principal investigator
Immunology Section, Laboratori. UDIAT-CD. Corporació Sanitària i Universitària Parc Taulí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease Patients Following Recommendations of ESPGHAN and HLA-DQ2 Typing Include HLA-DR7-DQ2 Haplotypes, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-tissue transglutaminase (time frame: Up to 1 month after diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2013.