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Safety Study of P28GST Treatment in Crohn's Disease Patients (ACROHNEM)

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: NCT02281916
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : June 11, 2018
Sponsor:
Collaborators:
National Research Agency, France
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date  ICMJE October 28, 2014
First Posted Date  ICMJE November 4, 2014
Last Update Posted Date June 11, 2018
Study Start Date  ICMJE March 2014
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2016)		 Number of participants wtih adverse events as a measure of safety and tolerability [ Time Frame: up to one year ]
Clinical and blood markers change from baseline
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2014)		 Number of participant wtih adverse events as a measure of safety and tolerability [ Time Frame: up to one year ]
Clinical and blood markers change from baseline
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • Main immunologic and inflammatory blood and tissue markers. [ Time Frame: up to one year ]
  • Appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index) and confirmed by a morphologic examination. [ Time Frame: up to one year ]
  • Intestinal microbiota [ Time Frame: at inclusion, at 4 month , at 12 month ]
    Evolution of bacterial species by genomic analysis
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
  • Main immunologic and inflammatory blood and tissues markers. [ Time Frame: up to one year ]
  • Appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index) and confirmed by a morphologic examination. [ Time Frame: up to one year ]
  • Appearance or not of a recurrence at 6 months assessed by the endoscopic scoring system of Rutgeerts [ Time Frame: month 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of P28GST Treatment in Crohn's Disease Patients
Official Title  ICMJE Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial
Brief Summary This multicenter phase 2 clinical trial is designed to assess safety of P28GST (protein 28 Kd glutathion S Transferrase), aiming to control inflammation in moderate Crohn's Disease (CD), before or after intestinal resection surgery. P28GST is a parasite enzyme molecule from Schistosoma with potent immunogenic and anti-oxidant properties. Based on experimental evidence of its anti-inflammatory properties, the investigators hypothesized that administration of P28GST could protect against recurrence after intestinal resection surgery in CD.
Detailed Description To carry out this study, 24 moderate CD patients will be enrolled in a safety phase 2a study. CD patients will be included after intestinal resection surgery or in moderate Crohn's Disease (CD). Drug therapy will consisted in 3 injections of 100 µg of P28GST within 3 months (one injection per month). The main objective of this study is to follow-up monthly rate and seriousness of adverse events during one year. Secondary objectives are to control immunologic and inflammatory blood and tissue markers, appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Ileocolitis
Intervention  ICMJE Drug: P28GST
3 injections of 100 µg of P28GST within 3 months (one injection per month)
Other Name: immunotherapy
Study Arms  ICMJE Experimental: P28GST treatment
P28GST as a parasite enzyme
Intervention: Drug: P28GST
Publications * Foligne B, Ple C, Titecat M, Dendooven A, Pagny A, Daniel C, Singer E, Pottier M, Bertin B, Neut C, Deplanque D, Dubuquoy L, Desreumaux P, Capron M, Standaert A. Contribution of the Gut Microbiota in P28GST-Mediated Anti-Inflammatory Effects: Experimental and Clinical Insights. Cells. 2019 Jun 12;8(6):577. doi: 10.3390/cells8060577.

*   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: June 7, 2018)		 10
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2014)		 24
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects between the ages of ≥18 years at inclusion.
  • Subjects with ileal or ileo-colic CD without fistula
  • Subjects operated or not
  • CDAI score < 220
  • no concomitant treatment excepted salicylates
  • Women of child bearing potential must be negative for pregnancy prior to study enrolment
  • contraceptive means : females of childbearing potential as well as males are required to use adequate contraceptive methods for 6 months starting at the inclusion, i;e 4 months after the 3rd injection .
  • No tobacco consumption (end date of tobacco consumption 8 days before surgery).
  • Signed consent form
  • French social security coverage.

Exclusion Criteria:

  • Subject who use of azathioprine, anti-TNF (Tumor Necrosis Factor), methotrexate, Vedolizumab, Ustekinumab and other immunosuppressors for 8 weeks before first injection of P28GST
  • Subject who use of corticosteroids for 15 days before first injection of P28GST
  • Subject with history of vaccine hyper sensitivity or allergy.
  • Subject with any other clinical manifestation determined by the investigator
  • Subject wih AIDS, B or C hepatitis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02281916
Other Study ID Numbers  ICMJE 2013_02
2013-000595-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party University Hospital, Lille
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Lille
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Research Agency, France
  • Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Study Chair: Dominique DEPLANQUE, MD, PhD Lille University Hospital
PRS Account University Hospital, Lille
Verification Date June 2018

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