NCT01947907

Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Ascendis Pharma A/S · Industry
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Growth Hormone Deficiency (GHD)

Interventions

Type	Name	Description
DRUG	ACP-001	Once weekly subcutaneous injection
DRUG	Human Growth Hormone	Once daily subcutaneous injection of human Growth Hormone

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-07-01
• Completion: 2015-09-01
• First posted: 2013-09-23
• Last updated: 2017-01-19
• Results posted: 2017-01-19

Locations

36 sites across 14 countries: Belarus, Bulgaria, Czechia, Egypt, France, Germany, Greece, Hungary, Poland, Romania, Russia, Slovenia, Turkey (Türkiye), Ukraine