Safety and Efficacy of Varying Methods of ALV003 Administration for the Treatment of Celiac Disease
NCT ID: NCT01255696
Last Updated: 2012-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2010-11-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALV003
ALV003 is an orally administered mixture of two recombinant proteases (cysteine endoprotease B-isoform 2 and prolyl endopeptidase) engineered to degrade gluten into non-immunogenic fragments, by targeting the glutamine and proline residues common in gluten.
ALV003
Placebo
Excipients for ALV003 absent the experimental compounds
ALV003 placebo
Interventions
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ALV003
ALV003 placebo
Eligibility Criteria
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Inclusion Criteria
* Adherence to a gluten-free diet
* TG2 antibody negative
* Signed informed consent
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Alvine Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Marja-Leena Lähdeaho, MD
Role: PRINCIPAL_INVESTIGATOR
FINN-MEDI Research Oy
Markku Mäki, MD, PhD
Role: STUDY_CHAIR
Tampere University
Locations
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Terveystalo Kuopio
Kuopio, , Finland
Oulu Diakonissalaitos (ODL)
Oulu, , Finland
FINN-MEDI Research Oy - Clinical Trials Center
Tampere, , Finland
Countries
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References
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Lahdeaho ML, Kaukinen K, Laurila K, Vuotikka P, Koivurova OP, Karja-Lahdensuu T, Marcantonio A, Adelman DC, Maki M. Glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease. Gastroenterology. 2014 Jun;146(7):1649-58. doi: 10.1053/j.gastro.2014.02.031. Epub 2014 Feb 25.
Other Identifiers
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2010-023127-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALV003-1021
Identifier Type: -
Identifier Source: org_study_id