Status:
COMPLETED
Safety and Efficacy of Varying Methods of ALV003 Administration 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.
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 study participation
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01255696
Start Date
November 1 2010
End Date
June 1 2011
Last Update
August 6 2012
Active Locations (3)
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1
Terveystalo Kuopio
Kuopio, Finland
2
Oulu Diakonissalaitos (ODL)
Oulu, Finland
3
FINN-MEDI Research Oy - Clinical Trials Center
Tampere, Finland