Safety and Efficacy of Varying Methods of ALV003 Administration for the Treatment of Celiac Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alvine Pharmaceuticals Inc.

ClinicalTrials.gov Identifier:

NCT01255696

First received: December 3, 2010

Last updated: July 30, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 3, 2010

Last Updated Date

July 30, 2012

Start Date ^ICMJE

November 2010

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy: Intestinal mucosal morphology [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Intestinal mucosal morphology - change from baseline to week 6
Safety: Tolerability of ALV003 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts

Original Primary Outcome Measures ^ICMJE

Efficacy: Intestinal mucosal morphology [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Safety: Tolerability of ALV003 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Safety will be evaluated by collection of adverse events, blood chemistry and blood cell counts

Change History

Complete list of historical versions of study NCT01255696 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Intestinal intraepithelial lymphocyte numbers/phenotype - change from baseline to week 6
Efficacy: Change in serological markers of celiac disease [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Serological markers of celiac disease - change from baseline to week 6

Original Secondary Outcome Measures ^ICMJE

Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Efficacy: Change in serological markers of celiac disease [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Varying Methods of ALV003 Administration for the Treatment of Celiac Disease

Official Title ^ICMJE

A Phase 2a, Double-Blind, Placebo Controlled Study of the Efficacy, Safety and Tolerability of 6-weeks Treatment With Varying Methods of ALV003 Administration in Patients With Well-Controlled Celiac Disease

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Celiac Disease

Intervention ^ICMJE

Biological: ALV003
Biological: ALV003 placebo

Study Arm (s)

Experimental: 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.

Intervention: Biological: ALV003
Placebo Comparator: Placebo
Excipients for ALV003 absent the experimental compounds

Intervention: Biological: ALV003 placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 study participation

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT01255696

Other Study ID Numbers ^ICMJE

ALV003-1021, 2010-023127-23

Has Data Monitoring Committee

Responsible Party

Alvine Pharmaceuticals Inc.

Study Sponsor ^ICMJE

Alvine Pharmaceuticals Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Marja-Leena Lähdeaho, MD	FINN-MEDI Research Oy
Study Chair:	Markku Mäki, MD, PhD	University of Tampere

Information Provided By

Alvine Pharmaceuticals Inc.

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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