Status:
UNKNOWN
Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients
Lead Sponsor:
Alvine Pharmaceuticals Inc.
Conditions:
Celiac Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01917630
Start Date
August 1 2013
End Date
June 1 2015
Last Update
December 17 2014
Active Locations (88)
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1
Decatur, Alabama, United States, 35601
2
Huntsville, Alabama, United States, 35801
3
Huntsville, Alabama, United States, 35802
4
Scottsdale, Arizona, United States, 85259