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

Incidence of Anti-hGH Binding Antibody Formation

Number of subjects with positive results for anti-hGH binding antibodies at two consecutive post-dose visits

Time frame: Visit 2 - Visit 5

Incidence of Anti-hGH Neutralizing Antibody Formation

Number of subjects with positive results for anti-hGH neutralizing antibodies at two consecutive post-dose visits

Time frame: Visit 2 - Visit 5

Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)

Assessment of local tolerability was performed by examining injection sites (by the investigator during study visits) and on the basis of anamnestic data and records in the Patient Diary. Assessments included pain, redness, bruising, swelling, and itching. Every subject was counted only once within each symptom category.

Time frame: Start of study treatment through Visit 5 (Week 27)

Cmax of hGH

As part of the following endpoint: PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the pharmacokinetic (PK) profile of hGH from the daily rhGH groups during visit 1 and 3. Uncorrected Cmax (maximum value of concentration) values at Visit 3 (Week 13)

Time frame: 0 hours to 168 hours at Visit 3 (Week 13)

AUC0-168h of hGH

As part of the following endpoint: PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the PK profile of hGH from the daily rhGH group during Visit 1 and Visit 3 Uncorrected AUC0-168h (area under the curve from 0h to 168h) values at Visit 3 (Week 13)

Time frame: 0 hours to 168 hours at Visit 3 (Week 13)

E-Trough of IGF-1

As part of the following endpoint: PD profile of serum IGF-1 during Visit 1 and Visit 3 compared between the ACP-001 dose groups and to the daily rhGH group Uncorrected E-Trough (the pre-dose efficacy response) values at Week 13