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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Alvine Pharmaceuticals Inc.

Study Description
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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 Design
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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

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01917630


  Show 88 Study Locations
Sponsors and Collaborators
Alvine Pharmaceuticals Inc.
Investigators
Study Director: Daniel Adelman, MD Alvine Pharmaceuticals Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alvine Pharmaceuticals Inc.
ClinicalTrials.gov 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