Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alvine Pharmaceuticals Inc.

Criteria

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