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 ]

Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12


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