Study of the Efficacy of AT1001 (Larazotide Acetate) to Treat Celiac Disease - Full Text View

Purpose

This study will look at one dose of AT1001 for efficacy and safety for the treatment of celiac disease.

The primary efficacy outcome is the rate of response to gluten.

Condition	Intervention	Phase
Celiac Disease	Drug: Larazotide acetate (AT1001) Drug: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase IIb, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of AT-1001 in Celiac Disease Subjects During a Gluten Challenge

Resource links provided by NLM:

Genetics Home Reference related topics: celiac disease

MedlinePlus related topics: Celiac Disease

U.S. FDA Resources

Further study details as provided by Alba Therapeutics:

Primary Outcome Measures:

Response to gluten [ Time Frame: 6 weeks ]

Secondary Outcome Measures:

Anti-transglutaminase [ Time Frame: 6 weeks ]


Enrollment:	42
Study Start Date:	April 2009
Study Completion Date:	April 2010
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AT1001 Active	Drug: Larazotide acetate (AT1001) One capsule TID given with gluten or gluten placebo
Placebo Comparator: Placebo	Drug: Placebo One capsule TID given with gluten or gluten placebo

Detailed Description:

This is an outpatient, randomized, double-blind multicenter study. Subjects will remain on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules will be administered TID 15 minutes before each meal (breakfast, lunch, and dinner). Gluten or gluten placebo capsules will be taken TID with each meal.

Eligibility


Ages Eligible for Study:	18 Years to 72 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age between 18 and 72 years, inclusive
Diagnosed with Celiac Disease for more than 12 months
Anti-tissue Transglutaminase (anti-tTG) less than 10 EU
On a gluten-free diet for at least 12 months
BMI between 18.5 and 38, inclusive

Exclusion Criteria:

Current smoker
Has chronic active GI disease other than Celiac Disease (e.g., Crohn's, colitis)
Has diabetes (Type 1 or Type 2)
Participated in any clinical drug study within the past 30 days or has had previous exposure to AT-1001
Presents with or has a history of dermatitis herpetiformis

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889473

Locations


United States, California
Study Site
Orange, California, United States
United States, Kansas
Study Site
Topeka, Kansas, United States
United States, Kentucky
Study Site
Lexington, Kentucky, United States
United States, Maryland
Study Site
Hagerstown, Maryland, United States
Study Site
Silver Spring, Maryland, United States
United States, Michigan
Study Site
Chesterfield, Michigan, United States
Study Site
Troy, Michigan, United States
United States, Minnesota
Study Site
Rochester, Minnesota, United States
United States, New York
Study Site
New York, New York, United States
United States, Oklahoma
Study Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Study Site
Paoli, Pennsylvania, United States
Study Site
Philadelphia, Pennsylvania, United States
Study Site
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Study Site
Franklin, Tennessee, United States
Canada, Alberta
Study Site
Edmonton, Alberta, Canada

Sponsors and Collaborators

Alba Therapeutics

Investigators


Study Director:	Francisco Leon, MD, PhD	Alba Therapeutics Inc

More Information


Responsible Party:	Alba Therapeutics
ClinicalTrials.gov Identifier:	NCT00889473 History of Changes
Other Study ID Numbers:	CLIN1001-006 Part B
Study First Received:	April 27, 2009
Last Updated:	July 12, 2012

Keywords provided by Alba Therapeutics:


Celiac Disease Gluten

Additional relevant MeSH terms:


Celiac Disease Malabsorption Syndromes Intestinal Diseases	Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases

ClinicalTrials.gov processed this record on June 23, 2017