Study of the Efficacy of AT1001 (Larazotide Acetate) to Treat Celiac Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alba Therapeutics
ClinicalTrials.gov Identifier:
NCT00889473
First received: April 27, 2009
Last updated: July 12, 2012
Last verified: January 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:


Further study details as provided by Alba Therapeutics:

Primary Outcome Measures:
  • Response to gluten [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-transglutaminase [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Current smoker
  2. Has chronic active GI disease other than Celiac Disease (e.g., Crohn's, colitis)
  3. Has diabetes (Type 1 or Type 2)
  4. Participated in any clinical drug study within the past 30 days or has had previous exposure to AT-1001
  5. 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

No publications provided

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
Health Authority: United States: Food and Drug Administration

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 October 02, 2014