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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00859391




Registration number
NCT00859391
Ethics application status
Date submitted
19/01/2009
Date registered
11/03/2009
Date last updated
11/06/2009

Titles & IDs
Public title
Effects of Gluten Digestion With ALV003
Scientific 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
Secondary ID [1] 0 0
ALV0801
Universal Trial Number (UTN)
Trial acronym
0801
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Celiac Disease 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 - Active - This group received gluten pre-treated with ALV003

2 - Placebo - This group received Gluten pre-treated with placebo.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The clinical response by symptom measurement before and after oral challenge
Timepoint [1] 0 0
Day 1 and Day 6
Primary outcome [2] 0 0
The immune response measured by ELISPOT testing and celiac disease serology
Timepoint [2] 0 0
Prior to and post 3-day gluten challenge
Secondary outcome [1] 0 0
Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo
Timepoint [1] 0 0
Day 1 and Day 14

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Networks Limited - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alvine Pharmaceuticals Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00859391
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregor Brown, MD
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries