Trial | NCT00778518  Report issue

Title

Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).
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).

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    arx201 ...

  • Study Participants

    36
Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).
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).
Study Started
Jul 31
2008
Primary Completion
Oct 31
2009
Study Completion
Oct 31
2009
Last Update
Oct 12
2009
Estimate

Drug ARX201

Reconstituted lyophilized drug product at 2.5 mg/wk; 3 periods over six months.

Drug ARX201

Reconstituted lyophilized drug product at 5.0 mg/wk; 3 periods over six months.

Drug ARX201

Reconstituted lyophilized drug product at 10.0 mg/wk; 3 periods over six months.

1 Active Comparator

low dose

2 Active Comparator

Medium dose

3 Active Comparator

High Dose

Criteria 

Inclusion Criteria:

18-30 years old
GHD of childhood onset
completed growth
IGF-1 <=2SDS
rhGH treatment naive
hGH levels below cut-off

Exclusion Criteria:

History of malignancy or intracranial tumors
ECG abnormality
ICH
hepatic dysfunction
renal impairment
major medical conditions
inadequate T4
positive for HBV, HCV, or HIV
alcohol or drug abuse
No Results Posted