A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon PEG hGH) in Adults With Growth Hormone Deficiency

Growth Hormone Deficient Adults Clinical Trial

Official title: A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients With Growth Hormone Deficiency

Status Completed

Clinical Trial Summary

This study investigates the pharmacokinetic profile (PK) and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth hormone product over a period of 4 weeks (4 weekly administrations versus 28 daily administrations).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficient Adults

• NCT number: NCT01247675
• Study type: Interventional
• Source: Ascendis Pharma A/S
• Status: Completed
• Phase: Phase 2
• Start date: November 2010
• Completion date: May 2011