Clinical Trial: Safety and Efficacy of Varying Methods of ALV003 Administration for the Treatment of Celiac Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2a, Double-Blind, Placebo Controlled Study of the Efficacy, Safety and Tolerability of 6-weeks Treatment With Varying Methods of ALV003 Administration in Patients With Well-Controlled

Brief Summary: A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.

Detailed Summary:
Sponsor: Alvine Pharmaceuticals Inc.

Current Primary Outcome:

• Efficacy: Intestinal mucosal morphology [ Time Frame: 6 weeks ]
  Intestinal mucosal morphology - change from baseline to week 6
• Safety: Tolerability of ALV003 [ Time Frame: 6 weeks ]
  Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts

Original Primary Outcome:

• Efficacy: Intestinal mucosal morphology [ Time Frame: 6 weeks ]
• Safety: Tolerability of ALV003 [ Time Frame: 6 weeks ]
  Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts

Current Secondary Outcome:

• Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype [ Time Frame: 6 weeks ]
  Intestinal intraepithelial lymphocyte numbers/phenotype - change from baseline to week 6
• Efficacy: Change in serological markers of celiac disease [ Time Frame: 6 weeks ]
  Serological markers of celiac disease - change from baseline to week 6

Original Secondary Outcome:

• Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype [ Time Frame: 6 weeks ]
• Efficacy: Change in serological markers of celiac disease [ Time Frame: 6 weeks ]

Information By: Alvine Pharmaceuticals Inc.

Dates:
Date Received: December 3, 2010
Date Started: November 2010
Date Completion:
Last Updated: July 30, 2012
Last Verified: July 2012