Trials / Completed
CompletedNCT00859391
Effects of Gluten Digestion With ALV003
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- Alvine Pharmaceuticals Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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
Conditions
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2009-03-11
- Last updated
- 2009-06-11
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT00859391. Inclusion in this directory is not an endorsement.