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

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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

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.

Condition or disease Intervention/treatment Phase
Crohn's Ileocolitis Drug: P28GST Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial
Study Start Date : March 2014
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: P28GST treatment
P28GST as a parasite enzyme
Drug: P28GST
3 injections of 100 µg of P28GST within 3 months (one injection per month)
Other Name: immunotherapy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Main immunologic and inflammatory blood and tissue markers. [ Time Frame: up to one year ]
  2. 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 ]
  3. Intestinal microbiota [ Time Frame: at inclusion, at 4 month , at 12 month ]
    Evolution of bacterial species by genomic analysis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281916


Locations
France
Centre hospitalier
Amiens, France
Centre Hospitalier de Boulogne
Boulogne sur mer, France
Centre Hospitalier Dunkerque
Dunkerque, France
CHRU, Hôpital Claude Huriez
Lille, France, 59037
Centre Hospitalier,
Valenciennes, France
Sponsors and Collaborators
University Hospital, Lille
National Research Agency, France
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Chair: Dominique DEPLANQUE, MD, PhD Lille University Hospital

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02281916     History of Changes
Other Study ID Numbers: 2013_02
2013-000595-15 ( EudraCT Number )
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Lille:
Crohn disease
Immunotherapy
Helminth antigen

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases