Clinical trial NCT00859391: Effects of Gluten Digestion With ALV003
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Keywords: Celiac Disease
Lead sponsor: Alvine Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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

Primary outcomes:
measure: The clinical response by symptom measurement before and after oral challenge
timeFrame: Day 1 and Day 6
measure: The immune response measured by ELISPOT testing and celiac disease serology
timeFrame: Prior to and post 3-day gluten challenge
Secondary outcomes:
measure: Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo
timeFrame: Day 1 and Day 14
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Networks Limited
state: Victoria
Study officials:
affiliation: The Alfred
name: Gregor Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: