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Protease Inhibitor
ALV003 for Celiac Disease
Phase 2
Waitlist Available
Research Sponsored by Alvine Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy: Intestinal mucosal morphometry
Secondary outcome measures
Efficacy: Intestinal intraepithelial lymphocyte density
Safety: safety and tolerability of ALV003
Other outcome measures
Celiac disease-specific serology
Quality of life
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALV003Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Latiglutenase
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Alvine Pharmaceuticals Inc.Lead Sponsor
6 Previous Clinical Trials
329 Total Patients Enrolled
6 Trials studying Celiac Disease
329 Patients Enrolled for Celiac Disease
Daniel Adelman, MDStudy DirectorAlvine Pharmaceuticals Inc.
1 Previous Clinical Trials
110 Total Patients Enrolled
1 Trials studying Celiac Disease
110 Patients Enrolled for Celiac Disease
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Florida
How old are they?
65+
What site did they apply to?
NCT01917630
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
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