Status:
COMPLETED
Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease
Lead Sponsor:
9 Meters Biopharma, Inc.
Conditions:
Celiac Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study was conducted to assess the safety and efficacy of larazotide acetate versus placebo in inducing remission in subjects with active celiac disease.
Detailed Description
This was an outpatient, randomized, parallel- group, double-blind, multicenter, 8-week study with three treatment arms: larazotide acetate 4 mg TID, larazotide acetate 8 mg TID and placebo TID in subj...
Eligibility Criteria
Inclusion
- Male and female adults with celiac disease (as demonstrated by duodenal/jejunal biopsy or by capsule endoscopy plus positive anti-tTG)
- Marsh score ≥ II at screening
- Positive serum anti-tTG antibodies as determined by screening serology
- Willing to comply with a gluten-free diet for the duration of the study
Exclusion
- Has refractory Celiac Disease or severe complications of celiac disease (eg, EATL-, ulcerative jejunitis, perforation, etc.)
- Has chronic active GI disease other than Celiac Disease
- Has diabetes (Type 1 or Type 2) or other autoimmune disease that might interfere with the conduct of the study
- Has hemoglobin value below 8.5 g/dL
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00620451
Start Date
February 1 2008
End Date
December 1 2009
Last Update
September 20 2017
Active Locations (33)
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1
Study Site
Orange, California, United States, 92868
2
Study Site
San Francisco, California, United States, 94115
3
Study Site
Torrington, Connecticut, United States, 06790
4
Study Site
Jacksonville, Florida, United States, 32207