Clinical Trial: Safety and Efficacy of ALV003 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 ALV003 In Patients With Well-Controlled Celiac Disease
Brief Summary: A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
Detailed Summary: Double-blind, placebo controlled study of the efficacy, safety and tolerability of 6-weeks treatment of ALV003 in patients with well-controlled celiac disease. Approximately 110 biopsy proven celiac disease patients will be randomized to treatment with ALV003 or placebo in a 1:1 ratio. Patients will be required to have a pre-dose and a post-treatment intestinal biopsy, and also will be required to ingest a foodstuff that contains a specified amount of gluten during the active phase of the study along with the study treatment. Patients will return to the clinic weekly for the first two weeks, then every two weeks thereafter for safety visits. Patients will return to the clinic 28 days after completion of treatment for final safety and follow-up. Safety will be closely monitored throughout the study including laboratory parameters and clinical assessment of adverse events.
Sponsor: Alvine Pharmaceuticals Inc.
Current Primary Outcome:
- Efficacy: Intestinal mucosal morphology [ Time Frame: 6 weeks ]
- Safety: Tolerability of ALV003 [ Time Frame: 6 weeks ]
Original Primary Outcome: Same as current
Current 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 ]
Original Secondary Outcome: Same as current
Information By: Alvine Pharmaceuticals Inc.
Dates:
Date Received: August 13, 2009
Date Started: August 2009
Date Completion:
Last Updated: July 30, 2012
Last Verified: July 2012
