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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00859391
Ethics application status
Date submitted
19/01/2009
Date registered
10/03/2009
Date last updated
9/06/2009

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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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

Summary results
Other publications