Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    alv003-0921
Previous Study | Return to List | Next Study

Safety and Efficacy of ALV003 for the Treatment of Celiac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00959114
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : August 6, 2012
Sponsor:
Information provided by (Responsible Party):
Alvine Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE August 13, 2009
First Posted Date  ICMJE August 14, 2009
Last Update Posted Date August 6, 2012
Study Start Date  ICMJE August 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2009)
  • Efficacy: Intestinal mucosal morphology [ Time Frame: 6 weeks ]
  • Safety: Tolerability of ALV003 [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2009)
  • Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype [ Time Frame: 6 weeks ]
  • Efficacy: Change in serological markers of celiac disease [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of ALV003 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 ALV003 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Celiac Disease
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • 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 comparator
    Excipients for ALV003 absent the experimental compounds
    Intervention: Biological: ALV003 placebo
Publications * Lähdeaho ML, Kaukinen K, Laurila K, Vuotikka P, Koivurova OP, Kärjä-Lahdensuu T, Marcantonio A, Adelman DC, Mäki 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.

*   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
Actual Enrollment  ICMJE
 (submitted: July 30, 2012)
74
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2009)
110
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date August 2010   (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 participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00959114
Other Study ID Numbers  ICMJE ALV003-0921
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alvine Pharmaceuticals Inc.
Study Sponsor  ICMJE Alvine Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marja-Leena Lähdeaho, MD, PhD FINN-MEDI Research
Study Chair: Markku Mäki, Prof, MD, PhD Tampere University
PRS Account 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