Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients
- Registration Number
- NCT01917630
- Lead Sponsor
- Alvine Pharmaceuticals Inc.
- 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 Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- Ages 18 to 80 years
- Physician diagnosed celiac disease
- Adherence to a gluten-free diet
- Experiencing symptoms of celiac disease over a 1-month period
- Willing to take study medication for 12 weeks
- Willing to comply with all study procedures
- Sign informed consent
Exclusion Criteria
- Active inflammatory bowel disease
- Active dermatitis herpetiformis
- Use of certain specific medications prior to entry
- History of alcohol or illicit drug abuse in previous 6 months
- Pregnant or lactating
- Received any experimental drug within 30 days of enrollment
- Uncontrolled chronic disease or condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALV003 ALV003 - Placebo placebo -
- Primary Outcome Measures
Name Time Method Efficacy: Intestinal mucosal morphometry 12 weeks Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12
- Secondary Outcome Measures
Name Time Method Efficacy: Intestinal intraepithelial lymphocyte density 12 weeks Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells)
Safety: safety and tolerability of ALV003 12 weeks Incidence of adverse events between baseline and week 12