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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00859391

Acronym

0801

Enrollment

Registered

2009-03-11

Start date

2008-05-31

Completion date

2008-06-30

Last updated

2009-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

Celiac Disease

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo	Day 1 and Day 14

Countries

Australia

Outcome results