101
Participants
Start Date
November 16, 2021
Primary Completion Date
June 13, 2024
Study Completion Date
June 13, 2024
Macimorelin
Dosage form: granules for oral solution, Dosage: 1.0 mg/kg body weight, Frequency and duration: single oral dose administration. Macimorelin will be supplied in single-use aluminum pouches (synonymous: sachets) each containing 63.6 mg macimorelin as acetate, which provide 0.5 mg/mL of macimorelin when dissolved in 120 mL of water. The excess amount of 3.6 mg represents an overfill, which is needed to obtain the target concentration.
Arginine
For the arginine GHST, R-Gene® 10 from Pfizer will be provided as labelled investigational medicinal product (IMP). After an overnight fast, soluble arginine hydrochloride (0.5 g/kg) will be given i.v. as an infusion with an infusion duration of 30 min.
Clonidine
"For the clonidine GHST, CATAPRESAN® 75 tablets (Boehringer Ingelheim) will be provided as labelled IMP. Each tablet contains 75 ug clonidine hydrochloride. The tablets will be provided in boxes containing 10 tablets. The target dose is 0.15 mg/m2 body surface with a dose range of 0.08 - 0.15 mg/m2. Maximum dose will be 0.25 mg.~After an overnight fast, clonidine (0.15 mg/m2 body surface) will be given orally."
Univerzitetni Klinicni Center Ljubljana - Pediatrics, Ljubljana
Children's University Hospital Kosice, Košice
Ankara University, Faculty of Medicine, Ankara
Antalya Training and Research Hospital, Antalya
Icahn School of Medicine at Mount Sinai, New York
"Institutul de Endocrinologie C.I. Parhon", Bucharest
Children's Hospital at Montefiore, The Bronx
University children's clinic Belgrade - Department of Endocrinology, Belgrade
Clinical Center Nis - Clinic for Children's Internal Medicine, Niš
Osp. dei Bambini V. Buzzi, ASST Fatebenefratelli Sacco, Milan
Institute for Child and Youth Health Care of Vojvodina - Endocrinology, Novi Sad
UNC Hospitals, Chapel Hill
Emory Healthcare-Children's Center, Atlanta
Evangelisches Klinikum Bethel, Bielefeld
John Hopkins All Children's Hospital, St. Petersburg
Kocaeli University Faculty of Medicine, Kocaeli
Azienda Ospedaliero-Universitaria di Parma Ospedale dei Bambini Pietro Barilla, Clinica Pediatrica, Parma
Azienda Ospedaliero-Universitaria Anna Meyer, Florence
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw
University of Minnesota, Masonic Children's Hospital, Minneapolis
Ospedale Pediatrico G. Salesi, Ancona
Karadeniz Technical University, Ortahisar
The Children's Mercy Hospital - Broadway, Kansas City
SPSK Nr 1 im. prof. Tadeusza Sokolowskiego PUM, Szczecin
Alchemi Research Center, Rosharon
Pediatric Endocrine Associates, p.c., Greenwood Village
National Institute of Children's Diseases, Bratislava
St. Luke's Children's Endocrinology, Boise
Angel Wing Clinic For Children With Diabetes, Tucson
Multicare Health System, Tacoma
Spitalul Cl. de Urgenta pentru Copii Louis Turcanu Timisoara, Timișoara
Cen Med de Diagn si Trat Amb NEOMED, Brasov
Spitalul Clinic Judetean Mures, Târgu Mureş
"Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi", Iași
"Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta", Constanța
Yerevan State Medical University after Mkhitar Heraci, Yerevan
JSC Maritime Hospital, Batumi
National Institute of Endocrinology, Tbilisi
TSMU Givi Jvania Pediatric Academic Clinik, Tbilisi
IRCCS Ospedale Pediatrico Bambino Gesù, Roma
MED-POLONIA Sp.z o.o., Poznan
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie, Rzeszów
Sana Monitoring, Bucharest
Medicover Hospitals, Bucharest
National Institute of Endocrinology and Diabetology, Ľubochňa
Lead Sponsor
AEterna Zentaris
INDUSTRY