Effects of Gluten Digestion With ALV003 | NCT00859391

Studies
Effects of Gluten Digestion With ALV003

NCT00859391

Sponsor

Alvine Pharmaceuticals Inc.

Status

Completed

Last Update Posted

Jun 11, 2009Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Celiac Disease

Interventions

Not provided

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jan 19, 2009

First Submission Date that Met QC Criteria

Mar 10, 2009

First Posted Date

Mar 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2009

Last Update Posted Date

Jun 11, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Label	Type	Description	Intervention Names
1 - Active		This group received gluten pre-treated with ALV003
2 - Placebo		This group received Gluten pre-treated with placebo.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The clinical response by symptom measurement before and after oral challenge		Day 1 and Day 6
The immune response measured by ELISPOT testing and celiac disease serology		Prior to and post 3-day gluten challenge

Secondary Outcomes

Measure	Description	Time Frame
Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo		Day 1 and Day 14

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Name	Affiliation	Role
Gregor Brown, MD	The Alfred	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Nucleus Networks Limited		Melbourne	Victoria	3004	Australia

ID	Term
D002446	Celiac Disease

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Description

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.