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

CHU de Saint Etienne0 个研究点目标入组 120 人开始时间: 2019年6月19日最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•- Patient with active UC
•- Patient with active ulcerative colitis who failed to anti-TNF (infliximab, adalimumab, golimumab) after induction (no primary response) or clinical recurrence (secondary failure).
•- Patient with endoscopic active disease with an endoscopic Mayo score> 2 and 2 biopsies of the inflammatory tissue.
•- Presence of a CMV infection in the inflammatory tissue objectified by a viral load greater than 5 IU / 100000 cells by qPCR.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Patient with severe acute colitis
•- Patient treated by ciclosporin or Prograf.
•- Clostridium difficile infection.
•- CMV positive viremia (strongly recommending the use of an anti-CMV in the recommendations of GETAID). Insofar as the patients included will be in thrust with CMV colic, it is licit to make a blood viremia
•- Patient with intolerance or contraindication to the treatment used
•- Pregnant or breastfeeding woman

发起方

CHU de Saint Etienne