Effects of Gluten Digestion With ALV003 (0801)

June 9, 2009 updated by: Alvine Pharmaceuticals Inc.

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

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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Nucleus Networks Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The target population for this study is patients with celiac disease with HLA DQ2 phenotype who have well controlled celiac disease without significant co-morbidities and are previously on a gluten free diet for at least 8 weeks prior to study entry.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1 - Active
This group received gluten pre-treated with ALV003
2 - Placebo
This group received Gluten pre-treated with placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The clinical response by symptom measurement before and after oral challenge
Time Frame: Day 1 and Day 6
Day 1 and Day 6
The immune response measured by ELISPOT testing and celiac disease serology
Time Frame: Prior to and post 3-day gluten challenge
Prior to and post 3-day gluten challenge

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvine Pharmaceuticals Inc.

Investigators

  • Principal Investigator: Gregor Brown, MD, The Alfred

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 19, 2009

First Submitted That Met QC Criteria

March 10, 2009

First Posted (Estimate)

March 11, 2009

Study Record Updates

Last Update Posted (Estimate)

June 11, 2009

Last Update Submitted That Met QC Criteria

June 9, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALV0801

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Celiac Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe