NCT04064697 (CYTOVEDO) is a Phase 3 clinical trial of Valganciclovir in Ulcerative Colitis, Unspecified, sponsored by Centre Hospitalier Universitaire de Saint Etienne.

Who is sponsoring NCT04064697?

NCT04064697 is sponsored by Centre Hospitalier Universitaire de Saint Etienne.

What drugs are being tested in NCT04064697?

Interventions in NCT04064697: Valganciclovir.

What condition does NCT04064697 study?

NCT04064697 studies Ulcerative Colitis, Unspecified.

Is NCT04064697 still recruiting?

NCT04064697 is currently terminated. Last updated 10 April 2024.

Last reviewed 2024-04-10 · How we verify

NCT04064697: CYTOVEDO

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy

Terminated Phase 3 Last updated 10 April 2024

What this trial tests

Phase 3 trial testing Valganciclovir in Ulcerative Colitis, Unspecified in 6 participants. Terminated before completion.

Timeline

22 April 2021

Primary endpoint
23 November 2023

8 February 2024

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Saint Etienne
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	22 April 2021
Primary completion	23 November 2023
Estimated completion	8 February 2024
Sites	8 locations across France

Drugs / interventions tested

Valganciclovir (VALGANCICLOVIR) — full drug profile →

Conditions studied

Ulcerative Colitis, Unspecified — all drugs for Ulcerative Colitis, Unspecified →

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Who can join

18 and older, any sex, with Ulcerative Colitis, Unspecified. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Integrins as Drug Targets in Vascular and Related Diseases.
Meredith E, Schwartz MA. · · 2024 · cited 2× · PMID 39703402 · DOI 10.53941/ijddp.2024.100010

Verify or expand the search:

Other trials of Valganciclovir

Trials testing the same drug.

NCT07513623 — Systemic and Topical Antiviral Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes - Trials I and II · Phase 2 · not yet recruiting
NCT07379203 — ValgaNciclovIR for CMV Viraemia in AdvaNced HIV diseAse · Phase 2 · not yet recruiting
NCT07079735 — Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant · Phase 2, PHASE3 · recruiting
NCT07266467 — Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Dis · Phase 4 · recruiting
NCT06034925 — Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients · Phase 4 · completed

Other Centre Hospitalier Universitaire de Saint Etienne trials

Trials by the same sponsor.

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NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07483710 — Association Between Muscle L3 CT Scan Muscle Derived Parameters of Muscle Function Upon Intensive Care Unit Admission an · NA · not yet recruiting
NCT06845176 — Combining Motor Imagery and Tendon Vibration on the Effectiveness of Motor Imagery · NA · recruiting
NCT07344298 — Less is Better? Effectiveness of a Short Local Vibration Protocol on Neuromuscular Function · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04064697 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Saint Etienne
Last refreshed: 10 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04064697.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing