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Effects of Gluten Digestion With ALV003 — 0801  

Celiac Disease Clinical Trial

Official title:
A Phase 0 Study in Subjects With Well Controlled Celiac Disease to Assess the Effects of Gluten Digestion With ALV003 (a Protease Enzyme) in Vitro

Clinical Trial Summary

This is a Phase 0, Double-blind study that will assess the effect of in vitro treatment of gluten with ALV003 or with placebo when ingested by CD Subjects.

Clinical Trial Description

The primary objective of this study is to compare the effects of gluten treated with ALV003 vs placebo:

- The clinical response by symptom measurement before and after oral challenge

- The immune response measured by ELISPOT testing and serology The secondary objective of the study is to

- Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00859391
Study type Observational
Source Alvine Pharmaceuticals Inc.
Contact
Status Completed
Phase Phase 0
Start date May 2008
Completion date June 2008
View Details
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