Status:
COMPLETED
Safety and Efficacy of ALV003 for the Treatment of Celiac Disease
Lead Sponsor:
Alvine Pharmaceuticals Inc.
Conditions:
Celiac Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- History of biopsy-proven celiac disease
- Adherence to a gluten-free diet
- TG2 antibody negative
- Signed informed consent
Exclusion
- Active dermatitis herpetiformis
- History of IgE-mediated reactions to gluten
- Use of specific medications 6 months prior to entry
- History of alcohol abuse or illicit drug use
- Current untreated or GI disease
- Positive pregnancy test
- Received any experimental drug within 14 days of randomization
- Uncontrolled chronic disease or condition
- Uncontrolled complications of celiac disease
- Any medical condition, which could adversely affect participation
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00959114
Start Date
August 1 2009
End Date
October 1 2010
Last Update
August 6 2012
Active Locations (1)
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1
FINN-MEDI Research - Clinical Trials Center
Tampere, Finland