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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
History of Changes

April 27, 2009
July 12, 2012
April 2009
November 2009   (final data collection date for primary outcome measure)
Response to gluten [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00889473 on ClinicalTrials.gov Archive Site
Anti-transglutaminase [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Efficacy of AT1001 (Larazotide Acetate) to Treat Celiac Disease
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

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Celiac Disease
  • Drug: Larazotide acetate (AT1001)
    One capsule TID given with gluten or gluten placebo
  • Drug: Placebo
    One capsule TID given with gluten or gluten placebo
  • Experimental: AT1001 Active
    Intervention: Drug: Larazotide acetate (AT1001)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
April 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 72 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00889473
CLIN1001-006 Part B
No
Alba Therapeutics
Alba Therapeutics
Not Provided
Study Director: Francisco Leon, MD, PhD Alba Therapeutics Inc
Alba Therapeutics
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP