Safety and Tolerability Study of AT1001 in Celiac Disease Subjects - Full Text View

Purpose

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.

Condition	Intervention	Phase
Celiac Disease	Drug: AT1001	Phase II

MedlinePlus related topics:

Celiac Disease

ChemIDplus related topics:

AT 1001

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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.

Further study details as provided by Alba Therapeutics:

Primary Outcome Measures:

To demonstrate the safety and tolerability of multiple, oral doses of AT-1001 in celiac disease subjects that maintain a gluten-free diet.

Secondary Outcome Measures:

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.

Estimated Enrollment:	79
Study Start Date:	August 2006
Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362856

Locations


United States, Arizona
	Research Site
	Scottsdale, Arizona, United States, 85259

United States, California

	San Diego, California, United States, 92123

United States, Massachusetts
	Research Site
	Boston, Massachusetts, United States, 02215

United States, Minnesota
	Research Site
	Rochester, Minnesota, United States, 55905

United States, New Jersey

	Morristown, New Jersey, United States, 07960

United States, North Dakota

	Bismarck, North Dakota, United States, 58501

United States, Pennsylvania

	Pittsburgh, Pennsylvania, United States, 15241
	Research Site
	Philadelphia, Pennsylvania, United States, 19107

United States, Virginia
	Research Site
	Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Alba Therapeutics

More Information

Study ID Numbers:	CLIN1001-004
First Received:	August 8, 2006
Last Updated:	November 12, 2007
ClinicalTrials.gov Identifier:	NCT00362856
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases

Digestive System Diseases

Gastrointestinal Diseases

Malabsorption Syndromes

Celiac Disease

Metabolic disorder

Intestinal Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Alba Therapeutics
Information provided by:	Alba Therapeutics
ClinicalTrials.gov Identifier:	NCT00362856