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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04064697
Other study ID # 18PH192
Secondary ID 2019-001032-54
Status Terminated
Phase Phase 3
First received
Last updated
Start date April 22, 2021
Est. completion date February 8, 2024

Study information

Verified date June 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ulcerative Colitis (UC) is an inflammatory bowel disease that can require the use of anti-TNF alpha therapy. When anti-TNF alpha failed to obtain a clinical response, the use of a new anti-integrin therapy, vedolizumab, can be proposed. The efficacy of vedolizumab has been assessed in a phase 3 study (GEMINI I), with response rates of 41.1% with vedolizumab vs 25.5% with placebo. CytoMegaloVirus (CMV) reactivation has been associated with resistance to steroid and to several lines of immunosuppressive therapy. Antiviral therapy was proven to decrease the tissue viral load and to restore the response to immunosuppressive therapies (up to 80% in small group of patients). A recent meta-analysis supports the use of valganciclovir in case of CytoMegaloVirus (CMV) reactivation in active Ulcerative Colitis (UC). Moreover, a study showed that the risk of CMV reactivation seems to be more important with vedolizumab than with anti TNF, and the risk of colectomy is higher in case of CytoMegaloVirus (CMV) reactivation (p<0.05).


Description:

The hypothesis of this study is in Ulcerative Colitis (UC) patients with tissue CytoMegaloVirus (CMV) reactivation ; not responding to anti-TNF or without anti-TNF ; a treatment with valganciclovir, added to vedolizumab, could improve the clinical response.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date February 8, 2024
Est. primary completion date November 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with moderate to severe active Ulcerative Colitis (UC) defined by a Mayo score greater than 5 - Patient with an inflammatory outbreak of Ulcerative Colitis (UC) : - without anti-TNF - under anti-TNF (infliximab, adalimumab, golimumab) after induction (no primary response) or clinical recurrence (secondary failure). - Having rectosigmoidoscopy with an endoscopic Mayo score= 2 with 2 biopsies of the inflammatory tissue - Presence of a CytoMegaloVirus (CMV) infection in the inflammatory tissue (viral load greater than 5 IU / 100000 cells by qPCR) - Patient with a negative pre-treatment assessment including HIV, HBV, HCV, HCV serology, a negative quantiferon or a history of tuberculosis preventive treatment adapted by Rifinah or Rimifon - Signed informed consent Exclusion Criteria: - Patient with severe acute colitis - Patient treated by ciclosporin or Prograf - Patient with Human Immunodeficiency Virus (HIV)+, hepatitis B, hepatitis C, tuberculosis - Clostridium difficile infection. - Patient with intolerance or contraindications to current therapy - Pregnant or starts breastfeeding - Patient who received a live vaccine in the month preceding the study - Patients with severe renal insufficiency defined by creatinine clearance <30ml/minute, or hemodialysed

Study Design


Intervention

Drug:
Valganciclovir
The experimental intervention consists of taking the treatment Valganciclovir 900 mg morning and evening for 3 weeks

Locations

Country Name City State
France CH d'Annecy Annecy
France CHU de Clermont-Ferrand Clermont-Ferrand
France CHU de Lyon Sud Lyon
France CHU de Montpellier Montpellier
France CHU de Nice Nice
France APHP - Hôpital Saint-Antoine Paris
France CHU ROUEN - Service Gastro-entérologie Rouen
France CHU de Saint Etienne Saint-Étienne

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical response Percentage of patients in clinical response. the clinical response is defined by the decrease in the total Mayo Score compared to the inclusion of at least 3 points and at least 30% with a decrease in the score of bleeding (item 2 of the Mayo sub-score) from at least one point or sub-score of bleeding from 0 or 1 point with or without anti-CMV treatment. The Mayo score includes 3 items: stool frequency, presence of blood in the stool, and overall assessment of the disease. Weeks 6
Secondary Clinical remission Percentage of patients in clinical remission defined by a total Mayo score <3 with an endoscopic score <2 and no clinical sub-score> 2. Weeks 6
Secondary Mucosal healing Percentage of patients in mucosal healing defined by endoscopic mayo score <2 Weeks 6
Secondary Viral load CytoMegaloVirus (CMV) Value of viral load CytoMegaloVirus (CMV) by qPCR on inflammatory tissue in IU / 100000 cells. Weeks 6
Secondary clinical remission Percentage of patients in clinical remission defined by a total Mayo score <3 with an endoscopic score <2 and no clinical sub-score> 2. Weeks 52
Secondary Rate of colectomy Percentage of patients who required colectomy Weeks 52
Secondary Adverse effects Number and severity of adverse effects Weeks 52
Secondary viral load of the Torque teno virus performed on the blood tube and tissue biopsies Week 6
See also
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Recruiting NCT03110198 - Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis Phase 4