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Safety and Efficacy of ALV003 for the Treatment of Celiac Disease

NCT00959114 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2012-08-06

No results posted yet for this study

Summary

A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.

Conditions

Interventions

BIOLOGICAL

ALV003

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

BIOLOGICAL

ALV003 placebo

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

Sponsors & Collaborators

  • Alvine Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Marja-Leena Lähdeaho, MD, PhD · FINN-MEDI Research

  • Markku Mäki, Prof, MD, PhD · Tampere University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-08-31
Completion
2010-10-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

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 NCT00959114 on ClinicalTrials.gov