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Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
Sponsor: Ascendis Pharma A/S
Summary
A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis. The primary aim is to demonstrate safety, pharmacokinetics and pharmacodynamics over a period of six months. A secondary objective is the comparison of height velocity (HV) of the ACP-001 treated groups to the daily hGH treatment group.
Official title: A Multicenter, Phase 2, Randomized, Open Label, Active-controlled, Parallel-group Study Investigating the Safety, Tolerability, and Efficacy of Different Dose Levels of ACP-001 Administered Once Weekly Versus Standard Daily rhGH Replacement Therapy in Pre-pubertal Children With Growth Hormone Deficiency (GHD)
Key Details
Gender
All
Age Range
3 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
53
Start Date
2013-07
Completion Date
2015-09
Last Updated
2026-07-08
Healthy Volunteers
No
Conditions
Interventions
ACP-001
Once weekly subcutaneous injection
Human Growth Hormone
Once daily subcutaneous injection of human Growth Hormone
Locations (36)
2nd Children City Clinic
Minsk, Belarus
University Multiprofile Hospital for Active Treatment (UMHAT) "Sv. Marina"
Varna, Bulgaria
Masaryk´s Hospital
Ústí nad Labem, Czechia
El Shatby University Hospital
Alexandria, Egypt
Ain Shams University Hospital
Cairo, Egypt
Cairo University Hospital
Cairo, Egypt
El Mansoura University Hospital
El Mansoura, Egypt
Hôpital des enfants Pellegrin
Bordeaux, France
Hôpital Jeanne de Flandre
Lille, France
Hôpital Femme-Mère-Enfant
Lyon, France
University Hospital Leipzig
Leipzig, Germany
University Children's Hospital Magdeburg
Magdeburg, Germany
Children's Hospital of Athens "P. A. Kyriakou"
Athens, Greece
Buda Children's Hospital
Budapest, Hungary
Heim Pal Children's Hospital
Budapest, Hungary
University of Pecs
Pécs, Hungary
University of Szeged
Szeged, Hungary
University Medical Hospital
Katowice, Poland
Medical University of Lublin
Lublin, Poland
Regional Hospital N°2 Rzeszow
Rzeszów, Poland
Children's Memorial Health Institute Warsaw
Warsaw, Poland
Emergency Clinical Hospital Cluj-Napoca
Cluj-Napoca, Romania
St. Spiridon County Clinic Emergency Hospital
Iași, Romania
Louis Turcanu Emergency Hospital for Children Timisoara
Timișoara, Romania
Federal State Budgetary Institution
Moscow, Russia
St. Petersburg State Pediatric Medical Academy
Saint Petersburg, Russia
Samara State Medical University
Samara, Russia
Bashkir State Medical University
Ufa, Russia
Children's University Hospital
Ljubljana, Slovenia
Ankara University School of Medicine
Ankara, Turkey (Türkiye)
Ege Üniversity
Izmir, Turkey (Türkiye)
Donetsk Regional Children Clinical Hospital
Donetsk, Ukraine
Kharkiv National Medical University
Kharkiv, Ukraine
Institute of Endocrinology and Metabolism
Kiev, Ukraine
Ukrainian Children Specialized Clinical Hospital
Kiev, Ukraine
Odessa National Medical University
Odesa, Ukraine