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Trial record 1 of 1 for:    03011931
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Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568]

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ClinicalTrials.gov Identifier: NCT03011931
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Immunogenics, LLC

Tracking Information
First Submitted Date  ICMJE October 3, 2016
First Posted Date  ICMJE January 6, 2017
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE March 2016
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
Compare simvastatin metabolism with intestinal biopsies [ Time Frame: Within one month of visit ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
  • Villous height and crypt depth [ Time Frame: Within 1 month of visit ]
    As measured in intestinal biopsies
  • Dietary interview [ Time Frame: At initial visit ]
    To determine whether the patient is strictly adherent, mostly adherent or non-adherent to a gluten-free diet
  • Urinalysis [ Time Frame: Prior to administration of simvastatin and at the 3-hour mark ]
    Looking for traces of gluten peptides
  • Serologic testing [ Time Frame: Prior to administration of simvastatin ]
    tTG IgA titer level determination
  • DNA sampling [ Time Frame: Prior to administration of simvastatin ]
    Genetic testing associated with celiac disease (DQ2 and DQ8)
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 Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568]
Official Title  ICMJE Simvastatin Metabolism as a Test for Celiac Disease Activity
Brief Summary To study the correlation between simvastatin metabolism by the enterocyte and the histologic state of the intestine in treated celiac disease.
Detailed Description A cross sectional design incorporating subjects with active celiac disease and healed celiac disease (based on clinically-obtained biopsies); and healthy individuals.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Celiac Disease
Intervention  ICMJE Drug: Simvastatin
20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review
Other Name: Zocor
Study Arms  ICMJE Experimental: Simvastatin
Simvastatin tablet, 20 mg, one time by mouth
Intervention: Drug: Simvastatin
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
Actual Enrollment  ICMJE
 (submitted: January 4, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2017)
50
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Gluten-free diet for at least 1 year
  2. Clinical endoscopy within the past month
  3. Biopsies must show no villous atrophy or villous blunting
  4. Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater

Exclusion Criteria:

  1. 1st degree relative with Celiac Disease
  2. Positive tTG IgA, already on simvastatin or statin agent
  3. Unable to stop non-steroidal or anti-inflammatory drugs
  4. Prior history of GI surgery other than appendectomy or cholecystectomy
  5. Taking drugs know to inhibit or activate CYP3A4
  6. Unable to avoid food known to inhibit CYP3A4
  7. History of a reaction to statin drugs in the past
  8. Pregnant or nursing women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03011931
Other Study ID Numbers  ICMJE 15-007568
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Immunogenics, LLC
Study Sponsor  ICMJE Immunogenics, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph A Murray, MD Mayo Clinic
PRS Account Immunogenics, LLC
Verification Date January 2020

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