NCT03571516 - Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2018

Primary Completion Date

September 24, 2020

Study Completion Date

September 24, 2020

Conditions

Short Bowel Syndrome

Interventions

DRUG

Teduglutide

SC injection of 0.05 mg/kg teduglutide will be administered QD into abdomen or into either the thigh or arm for 24 weeks.

OTHER

Standard Medical Therapy

Standard medical therapy will be administered for 24 weeks.

DEVICE

Syringe

Teduglutide will be administered using syringe (510k number: K980987).

DEVICE

Needle

Teduglutide will be administered using needle (510k number: K021475).

Trial Locations (8)

Groupe Hospitalier Pellegrin - Hôpital des Enfants, Bordeaux

Hopital Jeanne de Flandre - CHRU Lille, Lille

Helsingin yliopistollinen keskussairaala, Helsinki

Ospedale Pediatrico Bambino Gesù, Roma

Great Ormond Street Hospital for Children, London

Royal Manchester Children's Hospital, Manchester

Alder Hey Childrens Hospital, Liverpool

Birmingham Children's Hospital, Birmingham