Status:
COMPLETED
Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).
Lead Sponsor:
Ambrx, Inc.
Collaborating Sponsors:
Merck Serono International SA
Conditions:
Growth Hormone Deficiency
Eligibility:
MALE
18-30 years
Phase:
PHASE2
Brief Summary
Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).
Detailed Description
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...
Eligibility Criteria
Inclusion
- 18-30 years old
- GHD of childhood onset
- completed growth
- IGF-1 \<=2SDS
- rhGH treatment naive
- hGH levels below cut-off
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00778518
Start Date
July 1 2008
End Date
October 1 2009
Last Update
October 12 2009
Active Locations (1)
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1
Accelsiors CRO and Consultancy Services
Budapest, Hungary