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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02281916
Other study ID # 2013_02
Secondary ID 2013-000595-15
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2014
Est. completion date February 2018

Study information

Verified date June 2018
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
P28GST
3 injections of 100 µg of P28GST within 3 months (one injection per month)

Locations

Country Name City State
France Centre hospitalier Amiens
France Centre Hospitalier de Boulogne Boulogne sur mer
France Centre Hospitalier Dunkerque Dunkerque
France CHRU, Hôpital Claude Huriez Lille
France Centre Hospitalier, Valenciennes

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Lille Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants wtih adverse events as a measure of safety and tolerability Clinical and blood markers change from baseline up to one year
Secondary Main immunologic and inflammatory blood and tissue markers. up to one year
Secondary Appearance or not of a clinical recurrence assessed by CDAI (Crohn Disease Activity Index) and confirmed by a morphologic examination. up to one year
Secondary Intestinal microbiota Evolution of bacterial species by genomic analysis at inclusion, at 4 month , at 12 month
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Recruiting NCT04100005 - A Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
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