Effects of Gluten Digestion With ALV003
Completed
- Conditions
- Celiac Disease
- Registration Number
- NCT00859391
- Lead Sponsor
- Alvine Pharmaceuticals Inc.
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Age 18-75 years
- Well controlled Celiac Disease without flare in symptoms for the past 8 weeks
- History of biopsy proven Celiac Disease
- Able and willing to complete a symptom diary for 3 days prior and through 3 days post gluten challenge
- Been on a gluten free diet for 8 weeks prior to study entry
- Have normal celiac serology (anti- tTG level of <20 units/mL)
Exclusion Criteria
- Uncontrolled complications of celiac disease which in the opinion of the Investigator would impact their immune response, or pose an increased risk to the subject. (example: like type 1 diabetes or other autoimmune disease)
- Pregnant or breast feeding women, subjects of childbearing potential to use two methods of contraception
- Concomitant medications such as over the counter digestive enzymes, immunosuppressive therapies, anticoagulants, NSAIDs. Chronic medications for well-controlled chronic conditions are allowed.
- Clinically significant abnormal lab values, as determined by the PI:
- Untreated or active peptic ulcer disease, esophagitis, motility disorders or any gastrointestinal diseases.
- Positive pregnancy test within 7 days prior to study drug administration
- Known allergy or hypersensitivity to E.coli or E.coli derived proteins
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The clinical response by symptom measurement before and after oral challenge Day 1 and Day 6 The immune response measured by ELISPOT testing and celiac disease serology Prior to and post 3-day gluten challenge
- Secondary Outcome Measures
Name Time Method Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo Day 1 and Day 14
Trial Locations
- Locations (1)
Nucleus Networks Limited
🇦🇺Melbourne, Victoria, Australia