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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
Summary
This trial tests ALV003, a medication that breaks down gluten, in celiac disease patients. It aims to see if the drug can protect the small intestine and reduce symptoms by cutting gluten into harmless pieces. ALV003 is a combination of two substances that degrades gluten and has been shown to reduce gluten-induced damage in celiac disease patients.
Eligible Conditions
- Celiac Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy: Intestinal mucosal morphometry
Secondary study objectives
Efficacy: Intestinal intraepithelial lymphocyte density
Safety: safety and tolerability of ALV003
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
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