Study of the Efficacy of 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 Larazotide Acetate (AT-1001) in Celiac Disease Subjects During a Gluten Challenge
1 other identifier
interventional
42
2 countries
15
Brief Summary
This study is designed to evaluate the efficacy of a single dose 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 P25-P50 for phase_2
Started Apr 2009
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 27, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedSeptember 20, 2017
September 1, 2017
7 months
April 27, 2009
September 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to gluten
6 weeks
Secondary Outcomes (1)
Anti-transglutaminase
6 weeks
Study Arms (2)
Larazotide acetate 1 mg
EXPERIMENTALlarazotide acetate 1 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
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 (15)
Study Site
Orange, California, United States
Study Site
Topeka, Kansas, United States
Study Site
Lexington, Kentucky, United States
Study Site
Hagerstown, Maryland, United States
Study Site
Silver Spring, Maryland, United States
Study Site
Chesterfield, Michigan, United States
Study Site
Troy, Michigan, United States
Study Site
Rochester, Minnesota, United States
Study Site
New York, New York, United States
Study Site
Oklahoma City, Oklahoma, United States
Study Site
Paoli, Pennsylvania, United States
Study Site
Philadelphia, Pennsylvania, United States
Study Site
Pittsburgh, Pennsylvania, United States
Study Site
Franklin, Tennessee, United States
Study Site
Edmonton, Alberta, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Francisco Leon, MD, PhD
Alba Therapeutics Inc
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
April 27, 2009
First Posted
April 29, 2009
Study Start
April 1, 2009
Primary Completion
November 1, 2009
Study Completion
April 1, 2010
Last Updated
September 20, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share