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Effects of Gluten Digestion With ALV003 (0801)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00859391
Recruitment Status : Completed
First Posted : March 11, 2009
Last Update Posted : June 11, 2009
Sponsor:
Information provided by:
Alvine Pharmaceuticals Inc.

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.

Condition or disease
Celiac Disease

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

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : May 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

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



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

Secondary Outcome Measures :
  1. Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo [ Time Frame: Day 1 and Day 14 ]

Biospecimen Retention:   Samples With DNA
The enzyme linked immunospot (ELISPOT) assay is used in vaccine development, cancer research, infectious disease diagnosis and monitoring, autoimmune disease studies and allergy and transplantation research. The ELISPOT enables determination of the frequency of cytokine secreting cells. The ELISPOT is a combination of both immunoassay and bioassay because live cells are cultured in plates. This enables a very high sensitivity to detect cytokine secretion at a single cell level as secreted cytokine does not diffuse into media but is immediately membrane bound.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859391


Locations
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Australia, Victoria
Nucleus Networks Limited
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Alvine Pharmaceuticals Inc.
Investigators
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Principal Investigator: Gregor Brown, MD The Alfred
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Responsible Party: Dr Gregor Brown, Principal Investigator, Alfred Hospital
ClinicalTrials.gov Identifier: NCT00859391    
Other Study ID Numbers: ALV0801
First Posted: March 11, 2009    Key Record Dates
Last Update Posted: June 11, 2009
Last Verified: June 2009
Keywords provided by Alvine Pharmaceuticals Inc.:
Celiac Disease
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases