A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis

PHASE4CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

October 12, 2016

Primary Completion Date

June 11, 2020

Study Completion Date

February 2, 2021

Conditions
Pouchitis
Interventions
DRUG

Vedolizumab Placebo

Vedolizumab placebo-matching IV infusion

DRUG

Ciprofloxacin

Ciprofloxacin tablets

DRUG

Vedolizumab

Vedolizumab IV infusion

Trial Locations (34)

3000

UZ Leuven - University Hospital Gasthuisberg, Leuven

13353

Charite Universitatsmedizin Berlin -Campus Virchow Klinikum, Berlin

20089

Istituto Clinico Humanitas IRCCS, Rozzano

22559

Asklepios Hospital Hamburg - West, Hamburg

27599

University of North Carolina GI, Chapel Hill

28204

Carolinas HealthCare System Digestive Health, Charlotte

31059

CHU de Toulouse - Hopital Rangueil, Toulouse

35010

Hospital Doctor Negrin, Las Palmas de Gran Canaria

35033

CHU de Rennes - Hopital de Pontchaillou, Rennes

35128

Azienda Ospedaliera di Padova, Padua

40138

Azienda Ospedaliera S. Orsola-Malpighi, Bologna

42270

CHU Saint Etienne - Hopital Nord, Saint-Priest-en-Jarez

44195

Cleveland Clinic Foundation, Cleveland

46026

Hospital Universitario y Politecnico La Fe, Valencia

54511

CHRU Nancy Hopital de Brabois, Vandœuvre-lès-Nancy

55455

University of Minnesota, Minneapolis

55905

Mayo Clinic, Rochester

60201

Northshore University HealthSystem, Evanston

60637

University of Chicago Medical Center, Chicago

68167

Klinikum Mannheim GmbH Universitaetsklinikum, Mannheim

69121

Praxis fuer Gastroenterologie, Drs. Ehehalt/ Helmstaedter, Heidelberg

76092

Texas Digestive Disease Consultants, Southlake

84132

University of Utah Health Sciences Center, Salt Lake City

37212-1375

Vanderbilt University Medical Center, Nashville

V6Z 2K5

GIRI (GI Research Institute), Vancouver

K1H 8L6

Ottawa Hospital - General Campus, Ottawa

M5G 1X5

Mount Sinai Hospital, Toronto

07747

Universitatsklinikum Jena, Jena

00168

Policlinico Gemelli, Rome

1105 AZ

Academic Medical Center, Amsterdam

6229 HX

Maastricht University Medical Center, Maastricht

HA1 3UJ

St. Mark's Hospital, Harrow

E1 2EF

Royal London Hospital, London

OX3 9DU

John Radcliffe Hospital, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY