44
Participants
Start Date
December 7, 2017
Primary Completion Date
March 6, 2020
Study Completion Date
March 6, 2020
MOD-4023
"MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.~MOD-4023 will be administered as a SC injection once weekly, using a delivery device."
Genotropin
"Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.~A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.~Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week)."
Aichi Medical University Hospital, Nagakute
Seirei Sakura Citizen Hospital, Sakura
Hospital of the University of Occupational and Environmental Health, Kitakyushu
Gunma University Hospital, Maebashi
Fukuyama City Hospital, Fukuyama
National Hospital Organization Kure Medical Center & Chugoku Cancer Center, Kure
Onomichi General Hospital, Onomichi
Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital, Asahikawa
Asahikawa Medical University Hospital, Asahikawa
KKR Sapporo Medical Center, Sapporo
Kobe University Hospital, Kobe
Takahashi Clinic, Kobe
Takarazuka City Hospital, Takarazuka
St. Marianna University School of Medicine Hospital, Kawasaki
National Hospital Organization Minami Kyoto Hospital, Jōyō
East Japan Railway Company Sendai Branch Office JR Sendai Hospital, Sendai
National University Corporation Tohoku University Tohoku University Hospital, Sendai
Igarashi childrens clinic, Sendai
Oita University Hospital, Yufu
Osaka Women's and Children's Hospital, Izumi
Osaka University Hospital, Suita
Saitama Medical University Hospital, Iruma-Gun
Saitama Medical Center, Kawagoe
Shimane University Hospital, Izumo
Tokyo Metropolitan Childrens Medical Center, Fuchū
National Center for Child Health and Development, Setagaya-Ku
Keio University Hospital, Shinjuku
Teikyo University Hospital, tabashi City
Tottori University Hospital, Yonago
Akita University Hospital, Akita
Fukuoka Children's Hospital, Fukuoka
Gifu University Hospital, Gifu
Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital, Hiroshima
Kumamoto University Hospital, Kumamoto
Miyazaki Prefectural Miyazaki Hospital, Miyazaki
Arakawa Children's Clinic, Nagano
Nara Prefecture General Medical Center, Nara
Niigata University Medical & Dental Hospital, Niigata
Okayama Saiseikai General Hospital Outpatient Center, Okayama
National Hospital Organization Okayama Medical Center, Okayama
Osaka City General Hospital, Osaka
Osaka City University Hospital, Osaka
Saitama Childrens Medical Center, Saitama
Saitama City Hospital, Saitama
Shizuoka Childrens Hospital, Shizuoka
Toranomon Hospital, Tokyo
OPKO Health, Inc.
INDUSTRY