Clinical Trial: Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintaine
Brief Summary: To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.
Detailed Summary:
Sponsor: Alvine Pharmaceuticals Inc.
Current Primary Outcome: Efficacy: Intestinal mucosal morphometry [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Efficacy: Intestinal intraepithelial lymphocyte density [ Time Frame: 12 weeks ]Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells)
- Safety: safety and tolerability of ALV003 [ Time Frame: 12 weeks ]Incidence of adverse events between baseline and week 12
Original Secondary Outcome: Same as current
Information By: Alvine Pharmaceuticals Inc.
Dates:
Date Received: August 2, 2013
Date Started: August 2013
Date Completion: June 2015
Last Updated: December 16, 2014
Last Verified: December 2014