Celiac Disease0801NCT00859391
Effects of Gluten Digestion With ALV003
An observational study of Celiac Disease, run by Alvine Pharmaceuticals Inc. at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Celiac Disease
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- May 2008to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Active | This group received gluten pre-treated with ALV003 | |
| 2 - Placebo | This group received Gluten pre-treated with placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical response by symptom measurement before and after oral challenge
Measured: Day 1 and Day 6
The immune response measured by ELISPOT testing and celiac disease serology
Measured: Prior to and post 3-day gluten challenge
Secondary outcomes (1)
Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo
Measured: Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startMay 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvine Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gregor Brown, MD, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859391
- Sponsor's protocol ID
- ALV0801
- Acronym
- 0801
- Status last verified
- Jun 2009
- First submitted
- 19 Jan 2009
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00859391
- Acronym / sponsor ID
- 0801 / ALV0801
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alvine Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Active | – | –This group received gluten pre-treated with ALV003 |
| 2 - Placebo | – | –This group received Gluten pre-treated with placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The clinical response by symptom measurement before and after oral challenge
Time frame: 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
1 secondary outcome
Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo
Time frame: Day 1 and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregor Brown, MD principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Alvine Pharmaceuticals Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical response by symptom measurement before and after oral challenge (time frame: Day 1 and Day 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2009.