Effects of Gluten Digestion With ALV003

NCT ID: NCT00859391

Last Updated: 2009-06-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-06-30

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

Conditions

Celiac Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1 - Active

This group received gluten pre-treated with ALV003

No interventions assigned to this group

2 - Placebo

This group received Gluten pre-treated with placebo.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alvine Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Alfred Hospital

Principal Investigators

Gregor Brown, MD

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Locations

Nucleus Networks Limited

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

ALV0801

Identifier Type: -

Identifier Source: org_study_id