Status:
COMPLETED
Safety Study of P28GST Treatment in Crohn's Disease Patients
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
National Research Agency, France
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Crohn's Ileocolitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 aft...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02281916
Start Date
March 1 2014
End Date
February 1 2018
Last Update
December 22 2025
Active Locations (5)
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1
Centre hospitalier
Amiens, France
2
Centre Hospitalier de Boulogne
Boulogne-sur-Mer, France
3
Centre Hospitalier Dunkerque
Dunkirk, France
4
CHRU, Hôpital Claude Huriez
Lille, France, 59037