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

NCT01947907 ↗

Phase 2 Completed 53 enrolled Ascendis Pharma A/S

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2013-07
Primary completion: 2015-07
Completion: 2015-09

Publications

Chatelain P, Malievskiy O, Radziuk K, Senatorova G, Abdou MO, Vlachopapadopoulou E, Skorodok Y, Peterkova V, Leff JA, Beckert M; TransCon GH Working Group. A Randomized Phase 2 Study of Long-Acting TransCon GH vs Daily GH in Childhood GH Deficiency. J Clin Endocrinol Metab. 2017 May 1;102(5):1673-1682. doi: 10.1210/jc.2016-3776.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ACP-001	Protein / enzyme biologic	0.14 mg/kg	Subcutaneous
Subject	ACP-001	Protein / enzyme biologic	0.21 mg/kg	Subcutaneous
Subject	ACP-001	Protein / enzyme biologic	0.3 mg/kg	Subcutaneous
Comparator	Somatropin	Protein / enzyme biologic	0.03 mg/kg	Subcutaneous

Indications

No indication recorded.