Safety and Tolerability Study of AT1001 in Celiac Disease Subjects

This study has been completed.

Sponsor:

Information provided by:

Alba Therapeutics

ClinicalTrials.gov Identifier:

NCT00362856

First received: August 8, 2006

Last updated: November 12, 2007

Last verified: February 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	August 8, 2006
Last Updated Date	November 12, 2007
Start Date ^ICMJE	August 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: August 8, 2006)	To demonstrate the safety and tolerability of multiple, oral doses of AT-1001 in celiac disease subjects that maintain a gluten-free diet.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00362856 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 8, 2006)	To evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by gluten challenge to evaluate the effects of multiple dose levels of AT-1001 in preventing the induction of celiac disease signs and symptoms resulting from gluten challenge.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Tolerability Study of AT1001 in Celiac Disease Subjects
Official Title ^ICMJE	A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of AT-1001 in Celiac Disease Subjects During Gluten Challenge.
Brief Summary	There are no therapeutic products on the market for celiac disease today. Current treatment is limited to gluten free foods and a gluten-free diet. The main purpose of this study is to test how safe, efficacious and tolerable the study drug AT1001 is in subjects with diagnosed celiac disease. A second purpose is to study how your body responds to the drug when you ingest gluten. This response is determined by testing your urine, and by capturing your daily and weekly gastrointestinal symptoms associated with celiac disease.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Celiac Disease
Intervention ^ICMJE	Drug: AT1001
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	79
Completion Date	March 2007
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Must have been diagnosed with celiac disease by biopsy for ≥ 6 months (attending physician confirmation will be accepted in lieu of a biopsy report). Have a Anti-Tissue Transglutaminase (tTG) ≤ 10 EU as measured by serology. Must be on a gluten-free diet for at least the past 6 months. Exclusion Criteria: Have any chronic active GI disease other than celiac disease (e.g., IBS, Crohn's, Colitis). Have diabetes (Type 1 or Type 2). Chronically consumes non-steroidal anti-inflammatory agents ("NSAIDs") or takes proton-pump inhibitors. Consuming oral corticosteroids or immune suppressants.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00362856
Other Study ID Numbers ^ICMJE	CLIN1001-004
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Alba Therapeutics
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alba Therapeutics
Verification Date	February 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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