Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients
NCT ID: NCT01917630
Last Updated: 2014-12-17
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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UNKNOWN
PHASE2
500 participants
INTERVENTIONAL
2013-08-31
2015-06-30
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
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)
Placebo
placebo
Interventions
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ALV003
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)
placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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Alvine Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Adelman, MD
Role: STUDY_DIRECTOR
Alvine Pharmaceuticals Inc.
Locations
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Decatur, Alabama, United States
Huntsville, Alabama, United States
Huntsville, Alabama, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
Modesto, California, United States
Newport Beach, California, United States
Oceanside, California, United States
Orange, California, United States
Palo Alto, California, United States
Poway, California, United States
Roseville, California, United States
San Diego, California, United States
San Jose, California, United States
San Marcos, California, United States
Aurora, Colorado, United States
Bridgeport, Connecticut, United States
Boynton Beach, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Idaho Falls, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Oak Lawn, Illinois, United States
Des Moines, Iowa, United States
Topeka, Kansas, United States
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
Boston, Massachusetts, United States
Chesterfield, Michigan, United States
Wyoming, Michigan, United States
Rochester, Minnesota, United States
Jackson, Mississippi, United States
Kansas City, Missouri, United States
Mexico, Missouri, United States
Marlton, New Jersey, United States
Great Neck, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Salisbury, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Mentor, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Malvern, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Warwick, Rhode Island, United States
Mt. Pleasant, South Carolina, United States
Chattanooga, Tennessee, United States
Hermitage, Tennessee, United States
Houston, Texas, United States
Irving, Texas, United States
Southlake, Texas, United States
West Jordan, Utah, United States
Alexandria, Virginia, United States
Virginia Beach, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Tampere, , Finland
Galway, , Ireland
Oslo, , Norway
Sheffield, , United Kingdom
Countries
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References
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Syage JA, Murray JA, Green PHR, Khosla C. Latiglutenase Improves Symptoms in Seropositive Celiac Disease Patients While on a Gluten-Free Diet. Dig Dis Sci. 2017 Sep;62(9):2428-2432. doi: 10.1007/s10620-017-4687-7. Epub 2017 Jul 28.
Murray JA, Kelly CP, Green PHR, Marcantonio A, Wu TT, Maki M, Adelman DC; CeliAction Study Group of Investigators. No Difference Between Latiglutenase and Placebo in Reducing Villous Atrophy or Improving Symptoms in Patients With Symptomatic Celiac Disease. Gastroenterology. 2017 Mar;152(4):787-798.e2. doi: 10.1053/j.gastro.2016.11.004. Epub 2016 Nov 15.
Other Identifiers
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ALV003-1221
Identifier Type: -
Identifier Source: org_study_id