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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01917630
Recruitment Status : Unknown
Verified December 2014 by Alvine Pharmaceuticals Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 7, 2013
Last Update Posted : December 17, 2014
Information provided by (Responsible Party):
Alvine Pharmaceuticals Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: ALV003 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet
Study Start Date : August 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: ALV003 Drug: ALV003
ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)

Placebo Comparator: Placebo Drug: placebo

Primary Outcome Measures :
  1. Efficacy: Intestinal mucosal morphometry [ Time Frame: 12 weeks ]
    Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12

Secondary Outcome Measures :
  1. Efficacy: Intestinal intraepithelial lymphocyte density [ Time Frame: 12 weeks ]
    Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells)

  2. Safety: safety and tolerability of ALV003 [ Time Frame: 12 weeks ]
    Incidence of adverse events between baseline and week 12

Other Outcome Measures:
  1. Celiac disease-specific serology [ Time Frame: 12 weeks ]
  2. Quality of life [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01917630

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United States, Alabama
Decatur, Alabama, United States, 35601
Huntsville, Alabama, United States, 35801
Huntsville, Alabama, United States, 35802
United States, Arizona
Scottsdale, Arizona, United States, 85259
Scottsdale, Arizona, United States, 85260
Tucson, Arizona, United States, 85712
United States, California
Los Angeles, California, United States, 90025
Los Angeles, California, United States, 90027
Modesto, California, United States, 95355
Newport Beach, California, United States, 92660
Oceanside, California, United States, 92056
Orange, California, United States, 92868
Palo Alto, California, United States, 94301
Poway, California, United States, 92064
Roseville, California, United States, 95661
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San Marcos, California, United States, 92069
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Aurora, Colorado, United States, 80045
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Bridgeport, Connecticut, United States, 06606
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Boynton Beach, Florida, United States, 33426
Hollywood, Florida, United States, 33021
Jacksonville, Florida, United States, 32224
Jacksonville, Florida, United States, 32256
Largo, Florida, United States, 33777
Miami, Florida, United States, 33137
Miami, Florida, United States, 33165
Naples, Florida, United States, 34102
Orlando, Florida, United States, 32806
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Atlanta, Georgia, United States, 30328
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Idaho Falls, Idaho, United States, 83404
Meridian, Idaho, United States, 83642
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Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60637
Evanston, Illinois, United States, 60201
Oak Lawn, Illinois, United States, 60453
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Des Moines, Iowa, United States, 50266
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Topeka, Kansas, United States, 66606
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Baltimore, Maryland, United States, 21229
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Boston, Massachusetts, United States, 02215
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Chesterfield, Michigan, United States, 48047
Wyoming, Michigan, United States, 49519
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Rochester, Minnesota, United States, 55905
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Jackson, Mississippi, United States, 39202
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Kansas City, Missouri, United States, 64131
Mexico, Missouri, United States, 65265
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Marlton, New Jersey, United States, 08053
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Great Neck, New York, United States, 11023
New York, New York, United States, 10032
Poughkeepsie, New York, United States, 12601
Rochester, New York, United States, 14618
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Asheville, North Carolina, United States, 28801
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Winston-Salem, North Carolina, United States, 27103
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Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44122
Dayton, Ohio, United States, 45415
Mentor, Ohio, United States, 44060
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Oklahoma City, Oklahoma, United States, 73103
Tulsa, Oklahoma, United States, 74104
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Portland, Oregon, United States, 97225
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Malvern, Pennsylvania, United States, 19355
Philadelphia, Pennsylvania, United States, 19107
Pittsburgh, Pennsylvania, United States, 15243
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
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Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Chattanooga, Tennessee, United States, 37421
Hermitage, Tennessee, United States, 37076
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Houston, Texas, United States, 77094
Irving, Texas, United States, 75063
Southlake, Texas, United States, 76092
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West Jordan, Utah, United States, 84088
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Alexandria, Virginia, United States, 22304
Virginia Beach, Virginia, United States, 23454
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Bellevue, Washington, United States, 98004
Seattle, Washington, United States, 98104
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Madison, Wisconsin, United States, 53705
Milwaukee, Wisconsin, United States, 53215
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Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Ontario
Hamilton, Ontario, Canada, L8S 4K1
Ottawa, Ontario, Canada, K2H 7B3
Toronto, Ontario, Canada, M9C 4Z5
Tampere, Finland
Galway, Ireland
Oslo, Norway
United Kingdom
Sheffield, United Kingdom, S11 7FF
Sponsors and Collaborators
Alvine Pharmaceuticals Inc.
Study Director: Daniel Adelman, MD Alvine Pharmaceuticals Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alvine Pharmaceuticals Inc. Identifier: NCT01917630     History of Changes
Other Study ID Numbers: ALV003-1221
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014

Keywords provided by Alvine Pharmaceuticals Inc.:
Celiac disease
Gluten-free diet
Coeliac disease
Celiac sprue

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases