Effects of Gluten Digestion With ALV003

Celiac Disease Clinical Trial

— 0801  

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 Details — Status: Completed

Administrative data

• NCT number: NCT00859391
• Other study ID #: ALV0801
• Status: Completed
• Phase: Phase 0
• First received: January 19, 2009
• Last updated: June 9, 2009
• Start date: May 2008
• Est. completion date: June 2008

Study information

• Verified date: June 2009
• Source: Alvine Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Observational

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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Celiac Disease

Locations

Country	Name	City	State
Australia	Nucleus Networks Limited	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Alvine Pharmaceuticals Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clinical response by symptom measurement before and after oral challenge		Day 1 and Day 6	Yes
Primary	The immune response measured by ELISPOT testing and celiac disease serology		Prior to and post 3-day gluten challenge	Yes
Secondary	Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo		Day 1 and Day 14	Yes