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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:
ClinicalTrials.gov Identifier:
NCT01917630
First Posted: August 7, 2013
Last Update Posted: December 17, 2014
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.
Information provided by (Responsible Party):
Alvine Pharmaceuticals Inc.
August 2, 2013
August 7, 2013
December 17, 2014
August 2013
April 2015   (Final data collection date for primary outcome measure)
Efficacy: Intestinal mucosal morphometry [ Time Frame: 12 weeks ]
Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12
Same as current
Complete list of historical versions of study NCT01917630 on ClinicalTrials.gov Archive Site
  • 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
Same as current
  • Celiac disease-specific serology [ Time Frame: 12 weeks ]
  • Quality of life [ Time Frame: 12 weeks ]
Same as current
 
Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Celiac Disease
  • Drug: ALV003
    ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)
  • Drug: placebo
  • Experimental: ALV003
    Intervention: Drug: ALV003
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
500
June 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Finland,   Ireland,   Norway,   United Kingdom,   United States
 
 
NCT01917630
ALV003-1221
Yes
Not Provided
Not Provided
Alvine Pharmaceuticals Inc.
Alvine Pharmaceuticals Inc.
Not Provided
Study Director: Daniel Adelman, MD Alvine Pharmaceuticals Inc.
Alvine Pharmaceuticals Inc.
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP