A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

PHASE3RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 19, 2024

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Pouchitis
Interventions
DRUG

Vedolizumab

Vedolizumab intravenous infusion.

DRUG

Concomitant Antibiotic Therapy

Ciprofloxacin, metronidazole, vancomycin, amoxicillin clavulanate or rifaximin.

Trial Locations (14)

3000

RECRUITING

UZ Leuven, Leuven

8950

RECRUITING

Hospital Sant Joan de Deu, Esplugues de Llobregat

10000

RECRUITING

Children's Hospital Zagreb, Zagreb

16147

RECRUITING

Istituto G Gaslini Ospedale Pediatrico IRCCS, Genova

34137

RECRUITING

IRCCS Materno Infantile Burlo Garofolo, Trieste

46026

RECRUITING

Hospital Universitari I Politecnic La Fe de Valencia, Valencia

80138

RECRUITING

AOU dell'Universita degli Studi della Campania Luigi Vanvitelli, Napoli

98124

RECRUITING

Azienda Ospedaliero Universitaria, Policlinico Gaetano Martino, Messina

4920235

RECRUITING

Schneider Children's Medical Center of Israel, Petah Tikva

9103102

RECRUITING

Shaare Zedek Medical Center, Jerusalem

150 06

RECRUITING

Fakultni nemocnice v Motole, Pediatricka klinika 2, Prague

115 27

RECRUITING

Sotiria Thoracic Diseases Hospital, Dpt. of Gastroenterology, Building Z, Athens

00161

RECRUITING

Azienda Ospedaliero-Universitaria Policlinico Umberto I, Rome

04-730

RECRUITING

Instytut Pomnik-/Centrum Zdrowia dziecka, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY