Conditions: Growth Hormone Deficiency (GHD)
Keywords: Human Growth Hormone rhGH hGH GHD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Once weekly subcutaneous injection of ACP-001 arm 2: Once weekly subcutaneous injection of ACP-001 arm 3: Once weekly subcutaneous injection of ACP-001 arm 4: Once daily subcutaneous injection of human Growth Hormone (rhGH)

Interventions: intervention 1: ACP-001 intervention 2: Human Growth Hormone
Intervention descriptions: intervention 1: Once weekly subcutaneous injection intervention 2: Once daily subcutaneous injection of human Growth Hormone

Protocol document: