Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients

Alvine Pharmaceuticals

Status: Completed

Conditions: Celiac Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01560169

ALV003-1121

Details and patient eligibility

About

This is an evaluation of celiac-specific patient reported outcome instruments in celiac disease patients.

Enrollment: 110 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of biopsy proven celiac disease
• Adherence to a gluten-free diet (established patients only)
• TG2 negative (established patients only)
• TG2 positive (newly diagnosed patients only)
• Signed informed consent

Exclusion criteria

• History of IgE-mediated reactions to gluten
• Significant laboratory abnormalities
• History of untreated or GI disease
• Positive pregnancy test
• Any medical condition which could adversely affect study participation

Trial design

110 participants in 2 patient groups

Gluten challenge

Description:

Gluten containing or gluten-free study food in established celiac disease patients

Observation

Description:

Observation in newly diagnosed celiac disease patients