Overview

Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
9 Meters Biopharma, Inc.
Alba Therapeutics
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria

- 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