Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/30/-0001 |
| Start Date: | March 2012 |
| End Date: | June 2013 |
| Contact: | Annette Marcantonio, BS, MBA |
| Email: | amarcantonio@alvinepharma.com |
| Phone: | 650-596-2435 |
Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients
This is an evaluation of celiac-specific patient reported outcome instruments in celiac
disease patients.
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
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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