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

NCT01917630 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2014-12-17

No results posted yet for this 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.

Conditions

Interventions

DRUG

ALV003

ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)

DRUG

placebo

Sponsors & Collaborators

  • Alvine Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Adelman, MD · Alvine Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-04-30
Completion
2015-06-30

Countries

  • United States
  • Canada
  • Finland
  • Ireland
  • Norway
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01917630 on ClinicalTrials.gov