Growth Hormone Deficiency Clinical Trial
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 to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).
Status | Completed |
Enrollment | 36 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 30 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hungary | Accelsiors CRO and Consultancy Services | Budapest |
Lead Sponsor | Collaborator |
---|---|
Ambrx, Inc. | Merck Serono International SA |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Temporal profiling of circulating IGF-1 levels. | 3 period | Yes | |
Secondary | Body composition measurements at start of study and end of study | 6 months | No |
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