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Impact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab Therapy (CYTOVEDO)

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ClinicalTrials.gov Identifier: NCT04064697
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief 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).


Condition or disease Intervention/treatment Phase
Ulcerative Colitis, Unspecified Drug: Valganciclovir Phase 3

Detailed Description:
The hypothesis of this study is in Ulcerative Colitis (UC) patients with tissue CytoMegaloVirus (CMV) reactivation not responding to anti-TNF, a treatment with valganciclovir, added to vedolizumab, could improve the clinical response.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab Therapy: a Randomized Clinical Trial Comparing a Strategy With or Without Antiviral Therapy. CYTOVEDO Study
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
Patient will be treated by vedolizumab the standard of care alone.
Experimental: Experimental group
Patient will be treated by vedolizumab the standard of care associated at valganciclovir.
Drug: Valganciclovir
The experimental intervention consists of taking the treatment Valganciclovir 900 mg morning and evening for 3 weeks
Other Name: antiviral therapy




Primary Outcome Measures :
  1. Clinical response [ Time Frame: Weeks 6 ]
    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.


Secondary Outcome Measures :
  1. Clinical remission [ Time Frame: Weeks 6 ]
    Percentage of patients in clinical remission defined by a total Mayo score <3 with an endoscopic score <2 and no clinical sub-score> 2.

  2. Mucosal healing [ Time Frame: Weeks 6 ]
    Percentage of patients in mucosal healing defined by endoscopic mayo score <2

  3. Viral load CytoMegaloVirus (CMV) [ Time Frame: Weeks 6 ]
    Value of viral load CytoMegaloVirus (CMV) by qPCR on inflammatory tissue in IU / 100000 cells.

  4. clinical remission [ Time Frame: Weeks 52 ]
    Percentage of patients in clinical remission defined by a total Mayo score <3 with an endoscopic score <2 and no clinical sub-score> 2.

  5. Rate of colectomy [ Time Frame: Weeks 52 ]
    Percentage of patients who required colectomy

  6. Adverse effects [ Time Frame: Weeks 52 ]
    Number and severity of adverse effects



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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:

  • 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) 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.
  • CytoMegaloVirus (CMV) positive viremia
  • 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

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): NCT04064697


Contacts
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Contact: Pauline VEYRARD, MD (0)477828619 ext +33 pauline.veyrard@chu-st-etienne.fr
Contact: Marie PEURIERE, CRA (0)477120826 ext +33 Marie.Peuriere@chu-st-etienne.fr

Locations
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France
CH d'Annecy Not yet recruiting
Annecy, France
Principal Investigator: Frédéric Heluwaert, MD         
Sub-Investigator: Joanna Pofelski, MD         
CHU de Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France
Principal Investigator: Anthony Buisson, MD         
CHU de Grenoble Not yet recruiting
Grenoble, France
Principal Investigator: Nicolas Mathieu, MD         
CHU de Lyon Sud Not yet recruiting
Lyon, France
Principal Investigator: Stephane Nancey, PhD         
Sub-Investigator: Pauline Danion, MD         
Sub-Investigator: Bernard Flourie, MD         
Sub-Investigator: Gilles Boschetti, MD         
CHU de Montpellier Not yet recruiting
Montpellier, France
Principal Investigator: Romain Altwegg, MD         
Sub-Investigator: Lucile Boivineau, MD         
CHU de Nice Not yet recruiting
Nice, France
Principal Investigator: Jérôme Filippi, MD         
Sub-Investigator: Xavier Hebuterne, PhD         
Sub-Investigator: Nadia Arab, MD         
Sub-Investigator: Julie Benard, MD         
APHP - Hôpital Saint-Antoine Not yet recruiting
Paris, France
Principal Investigator: Harry Sokol, PhD         
CHU de Saint Etienne Not yet recruiting
Saint-Étienne, France
Principal Investigator: Pauline VEYRARD, MD         
Sub-Investigator: Xavier ROBLIN, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
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Principal Investigator: Pauline VEYRARD, MD CHU SAINT-ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04064697     History of Changes
Other Study ID Numbers: 18PH192
2019-001032-54 ( EudraCT Number )
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Ulcerative Colitis (UC)
CytoMegaloVirus (CMV)
Vedolizumab
Valganciclovir
Anti-TNF
Mayo score
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Antiviral Agents
Valganciclovir
Vedolizumab
Anti-Infective Agents
Gastrointestinal Agents