Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).
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|ClinicalTrials.gov Identifier: NCT00778518|
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : October 12, 2009
|Condition or disease||Intervention/treatment||Phase|
|Growth Hormone Deficiency||Drug: ARX201||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|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).|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
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.
- Temporal profiling of circulating IGF-1 levels. [ Time Frame: 3 period ]
- Body composition measurements at start of study and end of study [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00778518
|Accelsiors CRO and Consultancy Services|
|Study Director:||Mihaly Juhasz, MD||Accelsiors CRO & Consultancy Services|