Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01247675 | A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency | PHASE2 | COMPLETED | 37 | — | — | Nov 1, 2010 | May 1, 2011 | Mar 9, 2017 | 4 | Denmark, Germany +2 |
Assessment of local tolerability was performed by examining injection sites by the investigator during study visits, and on the basis of records in the Patient Diary. Assessments included erythema, swelling, or pain.
Number of subjects with treatment emergent anti-hGH binding antibodies
| Arm | Type | Description |
|---|---|---|
| ACP-001, 0.02 mg hGH/kg/wk | EXPERIMENTAL | Once weekly subcutaneous injection of ACP-001 equivalent to 0.02 mg hGH/kg/week for 4 weeks |
| ACP-001, 0.04 mg hGH/kg/wk | EXPERIMENTAL | Once weekly subcutaneous injection of ACP-001 equivalent to 0.04 mg hGH/kg/week for 4 weeks |
| ACP-001, 0.08 mg hGH/kg/wk | EXPERIMENTAL | Once weekly subcutaneous injection of ACP-001 equivalent to 0.08 mg hGH/kg/week for 4 weeks |
| Omnitrope, 0.04 mg hGH/kg/wk | ACTIVE_COMPARATOR | Once daily subcutaneous injection of human Growth Hormone (Omnitrope) equivalent to 0.04 mg hGH/kg/week for 4 weeks |
| Name | Type | Description |
|---|---|---|
| ACP-001 (TransCon hGH) | DRUG | s.c., weekly injection |
| Omnitrope | DRUG | s.c., daily injection |
Inclusion Criteria: * Male or female between 20 to 70 years * Body Mass Index (BMI, kg/m2) of 19.0 to 36.0 kg/m2, both inclusive * Adult Growth Hormone Deficient (AHGD) patients with documented growth hormone deficiency as defined in the Consensus guidelines for the diagnosis and treatment of adult...