Ulcerative colitis
Conditions
Interventions
Additional immunosuppressive therapies combined with anti-viral therapy (Ganciclovir 5mg/kg, twice a day, 2weeks)
Additional immunosuppressive therapies without administration of ganciclovir
Sponsors
Department of Gastroenterology and Hepatology, Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Moderately to severely active ulcerative colitis (total Mayo score of 6 points or more) 2) Patients with Mayo endoscopic subscore of 2 points or more 3) Patients who provided written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with proctitis 2) Patients with fulminant ulcerative colitis 3) Patients with serious infectious disease 4) Patients with severe bone marrow suppression 5) Patients with severe renal dysfunction 6) Patients with severe liver dysfunction 7) Patients with malignancy 8) Patients with total colectomy and subtotal colectomy 9) Patients who are pregnant or have the possibility of pregnancy 10) Patients whom investigators and subinvestigators considered to be inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response (at week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Clinical remission (at week 4) 2) Proportion of patients with positive for CMV 3) Change of viral load of CMV-DNA | — |
Countries
Japan
Contacts
Public ContactMinoru Matsuura
Kyoto University Hospital Division of Endoscopic Medicine
Outcome results
None listed