Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease
A Phase IIb, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge
1 other identifier
interventional
171
2 countries
23
Brief Summary
This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects with celiac disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2007
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedSeptember 20, 2017
September 1, 2017
1.2 years
June 25, 2007
September 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.
The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten
Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.
Secondary Outcomes (2)
Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals
Up to 6 weeks
To prospectively validate a composite, weighted index of celiac disease activity
GSRS was completed weekly throughout the study.
Study Arms (4)
Larazotide acetate 1 mg
EXPERIMENTALlarazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Larazotide acetate 4 mg
EXPERIMENTALlarazotide acetate 4 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Larazotide acetate 8 mg
EXPERIMENTALlarazotide acetate 8 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
Placebo
PLACEBO COMPARATORplacebo capsules TID + 900 mg gluten capsules TID for 6 weeks
Interventions
gelatin capsules
gelatin capsules
Eligibility Criteria
You may qualify if:
- Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months
- Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU.
- BMI between 18.5 and 38, inclusive.
You may not qualify if:
- Has chronic active GI disease other than celiac disease
- Has diabetes (Type 1 or Type 2).
- Unable to abstain from alcohol consumption or NSAID use for 48 hours prior to each intestinal permeability collection throughout the study.
- Has hemoglobin value below 8.5 g/dL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Study Site
Scottsdale, Arizona, 85259, United States
Study Site
Colorado Springs, Colorado, 80907, United States
Study Site
Chicago, Illinois, 60637, United States
Study Site
Lexington, Kentucky, 40536, United States
Study Site
Hagerstown, Maryland, 21740, United States
Study Site
Boston, Massachusetts, 02215, United States
Study Site
Troy, Michigan, 48084, United States
Study Site
Rochester, Minnesota, 55905, United States
Study Site
New York, New York, 10032, United States
Study Site
Asheville, North Carolina, 28801, United States
Study Site
Cleveland, Ohio, 44195, United States
Study Site
Philadelphia, Pennsylvania, 19107, United States
Study Site
Pittsburgh, Pennsylvania, 15243, United States
Study Site
Houston, Texas, 77030, United States
Study Site
Plano, Texas, 75093, United States
Study Site
Richmond, Virginia, 23298, United States
Study Site
Seattle, Washington, 98101, United States
Study Site
Edmonton, Alberta, Canada
Study Site
Kelowna, British Columbia, Canada
Study Site
Calgary, Canada
Study Site
Montreal, Canada
Study Site
Toronto, Canada
Study Site
Winnipeg, Canada
Related Publications (1)
Kelly CP, Green PH, Murray JA, Dimarino A, Colatrella A, Leffler DA, Alexander T, Arsenescu R, Leon F, Jiang JG, Arterburn LA, Paterson BM, Fedorak RN; Larazotide Acetate Celiac Disease Study Group. Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study. Aliment Pharmacol Ther. 2013 Jan;37(2):252-62. doi: 10.1111/apt.12147. Epub 2012 Nov 19.
PMID: 23163616RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Francisco Leon, MD, Ph.D.
Alba Therapeutics Corp
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2007
First Posted
June 27, 2007
Study Start
August 1, 2007
Primary Completion
October 1, 2008
Study Completion
March 1, 2009
Last Updated
September 20, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share