This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Alvine Pharmaceuticals Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01917630
First received: August 2, 2013
Last updated: December 16, 2014
Last verified: December 2014
  Purpose
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 Intervention Phase
Celiac Disease Drug: ALV003 Drug: placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alvine Pharmaceuticals Inc.:

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

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


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

Estimated Enrollment: 500
Study Start Date: August 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917630

  Hide Study Locations
Locations
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
San Diego, California, United States, 92114
San Jose, California, United States, 95117
San Marcos, California, United States, 92069
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Bridgeport, Connecticut, United States, 06606
United States, Florida
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
United States, Georgia
Atlanta, Georgia, United States, 30328
United States, Idaho
Idaho Falls, Idaho, United States, 83404
Meridian, Idaho, United States, 83642
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60637
Evanston, Illinois, United States, 60201
Oak Lawn, Illinois, United States, 60453
United States, Iowa
Des Moines, Iowa, United States, 50266
United States, Kansas
Topeka, Kansas, United States, 66606
United States, Maryland
Baltimore, Maryland, United States, 21229
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Michigan
Chesterfield, Michigan, United States, 48047
Wyoming, Michigan, United States, 49519
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Mississippi
Jackson, Mississippi, United States, 39202
United States, Missouri
Kansas City, Missouri, United States, 64131
Mexico, Missouri, United States, 65265
United States, New Jersey
Marlton, New Jersey, United States, 08053
United States, New York
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
United States, North Carolina
Asheville, North Carolina, United States, 28801
Salisbury, North Carolina, United States, 28144
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44122
Dayton, Ohio, United States, 45415
Mentor, Ohio, United States, 44060
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Portland, Oregon, United States, 97225
United States, Pennsylvania
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
United States, South Carolina
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Chattanooga, Tennessee, United States, 37421
Hermitage, Tennessee, United States, 37076
United States, Texas
Houston, Texas, United States, 77094
Irving, Texas, United States, 75063
Southlake, Texas, United States, 76092
United States, Utah
West Jordan, Utah, United States, 84088
United States, Virginia
Alexandria, Virginia, United States, 22304
Virginia Beach, Virginia, United States, 23454
United States, Washington
Bellevue, Washington, United States, 98004
Seattle, Washington, United States, 98104
United States, Wisconsin
Madison, Wisconsin, United States, 53705
Milwaukee, Wisconsin, United States, 53215
Canada, Alberta
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
Finland
Tampere, Finland
Ireland
Galway, Ireland
Norway
Oslo, Norway
United Kingdom
Sheffield, United Kingdom, S11 7FF
Sponsors and Collaborators
Alvine Pharmaceuticals Inc.
Investigators
Study Director: Daniel Adelman, MD Alvine Pharmaceuticals Inc.
  More Information

Responsible Party: Alvine Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01917630     History of Changes
Other Study ID Numbers: ALV003-1221
Study First Received: August 2, 2013
Last Updated: December 16, 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

ClinicalTrials.gov processed this record on August 17, 2017