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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00959114
Other study ID # ALV003-0921
Secondary ID
Status Completed
Phase Phase 2
First received August 13, 2009
Last updated July 30, 2012
Start date August 2009
Est. completion date October 2010

Study information

Verified date July 2012
Source Alvine Pharmaceuticals Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationFinland: Finnish Medicines Agency
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date October 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Finland FINN-MEDI Research - Clinical Trials Center Tampere

Sponsors (1)

Lead Sponsor Collaborator
Alvine Pharmaceuticals Inc.

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy: Intestinal mucosal morphology 6 weeks No
Primary Safety: Tolerability of ALV003 6 weeks Yes
Secondary Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype 6 weeks No
Secondary Efficacy: Change in serological markers of celiac disease 6 weeks No
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