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Safety and Efficacy of ALV003 for the Treatment of Celiac Disease

NCT ID: NCT00959114

Last Updated: 2012-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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Double-blind, placebo controlled study of the efficacy, safety and tolerability of 6-weeks treatment of ALV003 in patients with well-controlled celiac disease. Approximately 110 biopsy proven celiac disease patients will be randomized to treatment with ALV003 or placebo in a 1:1 ratio. Patients will be required to have a pre-dose and a post-treatment intestinal biopsy, and also will be required to ingest a foodstuff that contains a specified amount of gluten during the active phase of the study along with the study treatment. Patients will return to the clinic weekly for the first two weeks, then every two weeks thereafter for safety visits. Patients will return to the clinic 28 days after completion of treatment for final safety and follow-up. Safety will be closely monitored throughout the study including laboratory parameters and clinical assessment of adverse events.

Conditions

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Celiac Disease

Keywords

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Celiac Disease Coeliac Disease Celiac Sprue Keliakia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALV003

ALV003 is an orally administered mixture of two recombinant proteases (cysteine endoprotease B-isoform 2 and prolyl endopeptidase) engineered to degrade gluten into non-immunogenic fragments, by targeting the glutamine and proline residues common in gluten.

Group Type EXPERIMENTAL

ALV003

Intervention Type BIOLOGICAL

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

Placebo comparator

Excipients for ALV003 absent the experimental compounds

Group Type PLACEBO_COMPARATOR

ALV003 placebo

Intervention Type BIOLOGICAL

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

Interventions

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ALV003

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

Intervention Type BIOLOGICAL

ALV003 placebo

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* History of biopsy-proven celiac disease
* Adherence to a gluten-free diet
* TG2 antibody negative
* Signed informed consent

Exclusion Criteria

* Active dermatitis herpetiformis
* History of IgE-mediated reactions to gluten
* Use of specific medications 6 months prior to entry
* History of alcohol abuse or illicit drug use
* Current untreated or GI disease
* Positive pregnancy test
* Received any experimental drug within 14 days of randomization
* Uncontrolled chronic disease or condition
* Uncontrolled complications of celiac disease
* Any medical condition, which could adversely affect participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alvine Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marja-Leena Lähdeaho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

FINN-MEDI Research

Markku Mäki, Prof, MD, PhD

Role: STUDY_CHAIR

Tampere University

Locations

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FINN-MEDI Research - Clinical Trials Center

Tampere, , Finland

Site Status

Countries

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Finland

References

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Lahdeaho ML, Kaukinen K, Laurila K, Vuotikka P, Koivurova OP, Karja-Lahdensuu T, Marcantonio A, Adelman DC, Maki M. Glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease. Gastroenterology. 2014 Jun;146(7):1649-58. doi: 10.1053/j.gastro.2014.02.031. Epub 2014 Feb 25.

Reference Type DERIVED
PMID: 24583059 (View on PubMed)

Other Identifiers

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ALV003-0921

Identifier Type: -

Identifier Source: org_study_id