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

History of Changes

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:

Genetics Home Reference related topics: celiac disease

MedlinePlus related topics: Celiac Disease

U.S. FDA Resources

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

Show 88 Study Locations

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 September 21, 2017

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