Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).
Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Phase IIb Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).|
- Temporal profiling of circulating IGF-1 levels. [ Time Frame: 3 period ] [ Designated as safety issue: Yes ]
- Body composition measurements at start of study and end of study [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.
Active Comparator: 2
Reconstituted lyophilized drug product at 5.0 mg/wk; 3 periods over six months.
Active Comparator: 3
Reconstituted lyophilized drug product at 10.0 mg/wk; 3 periods over six months.
The primary objective of this study is to evaluate the safety, tolerability and pharmacodynamic response of three different ARX201 doses (PEG-ahGH) when administered repeatedly to young adult patients with childhood onset growth hormone deficiency (GHD).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778518
|Accelsiors CRO and Consultancy Services|
|Study Director:||Mihaly Juhasz, MD||Accelsiors CRO and Consultancy Services|