Ulcerative Colitis, UnspecifiedPhase 3CYTOVEDONCT04064697
Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy
A Phase 3 study testing Valganciclovir in people with Ulcerative Colitis, Unspecified, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Unspecified
- What is being tested?
- Valganciclovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 8 sitesFrance
- Study dates
- 22 Apr 2021to 8 Feb 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CH d'Annecy
Annecy
CHU de Clermont-Ferrand
Clermont-Ferrand
CHU de Lyon Sud
Lyon
CHU de Montpellier
Montpellier
CHU de Nice
Nice
APHP - Hôpital Saint-Antoine
Paris
CHU ROUEN - Service Gastro-entérologie
Rouen
CHU de Saint Etienne
Saint-Etienne
About this study
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.
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).
Read the detailed 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.
- Conditions
- Ulcerative Colitis, Unspecified
- Being tested
- Valganciclovir
- Keywords
- Ulcerative Colitis (UC), CytoMegaloVirus (CMV), Vedolizumab, Valganciclovir, Anti-TNF, Mayo score
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
Also called antiviral therapy
The experimental intervention consists of taking the treatment Valganciclovir 900 mg morning and evening for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patient will be treated by vedolizumab the standard of care alone. |
| Experimental group | Experimental | Patient will be treated by vedolizumab the standard of care associated at valganciclovir. Receives: Drug: Valganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 6
Secondary outcomes (7)
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.
Measured: Weeks 6
Mucosal healing
Percentage of patients in mucosal healing defined by endoscopic mayo score <2
Measured: Weeks 6
Viral load CytoMegaloVirus (CMV)
Value of viral load CytoMegaloVirus (CMV) by qPCR on inflammatory tissue in IU / 100000 cells.
Measured: Weeks 6
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.
Measured: Weeks 52
Rate of colectomy
Percentage of patients who required colectomy
Measured: Weeks 52
Adverse effects
Number and severity of adverse effects
Measured: Weeks 52
viral load of the Torque teno virus
performed on the blood tube and tissue biopsies
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start22 Apr 2021
- Primary completion23 Nov 2023
- Study completion8 Feb 2024
Why it stopped: low of inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Pauline VEYRARD, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064697
- Sponsor's protocol ID
- 18PH192
- Other IDs
- 2019-001032-54, 2019
- Acronym
- CYTOVEDO
- Status last verified
- Jun 2023
- First submitted
- 20 Aug 2019
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04064697
- Acronym / sponsor ID
- CYTOVEDO / 18PH192
- Conditions
- Ulcerative Colitis, Unspecified
- Keywords
- Ulcerative Colitis (UC), CytoMegaloVirus (CMV), Vedolizumab, Valganciclovir, Anti-TNF, Mayo score
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low of inclusions
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patient will be treated by vedolizumab the standard of care alone. |
| Experimental group | Experimental | Drug: ValganciclovirPatient will be treated by vedolizumab the standard of care associated at valganciclovir. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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) :
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValganciclovirAlso: antiviral therapyThe experimental intervention consists of taking the treatment Valganciclovir 900 mg morning and evening for 3 weeks | Drug | Experimental group |
Primary outcome
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.
7 secondary outcomes
Clinical remission
Time frame: Weeks 6
Mucosal healing
Time frame: Weeks 6
Viral load CytoMegaloVirus (CMV)
Time frame: Weeks 6
clinical remission
Time frame: Weeks 52
Rate of colectomy
Time frame: Weeks 52
Adverse effects
Time frame: Weeks 52
viral load of the Torque teno virus
Time frame: Week 6
Results and safety
The study was stopped early (reason given: low of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline VEYRARD, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valganciclovir in people with Ulcerative Colitis, Unspecified, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low of inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: Weeks 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.