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

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

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

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.

Resource links provided by NLM:

MedlinePlus related topics: Celiac Disease Diets

Drug Information available for: AT 1001

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	CLIN1001-004
Study First Received:	August 8, 2006
Last Updated:	November 12, 2007
ClinicalTrials.gov Identifier:	NCT00362856 History of Changes
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
Intestinal Diseases
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Digestive System Diseases
Gastrointestinal Diseases

Malabsorption Syndromes
Celiac Disease
Intestinal Diseases

ClinicalTrials.gov processed this record on September 02, 2009