Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).
- Registration Number
- NCT00778518
- Lead Sponsor
- Ambrx, Inc.
- 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 with childhood onset growth hormone deficiency (GHD).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 ARX201 High Dose 1 ARX201 low dose 2 ARX201 Medium dose
- Primary Outcome Measures
Name Time Method Temporal profiling of circulating IGF-1 levels. 3 period
- Secondary Outcome Measures
Name Time Method Body composition measurements at start of study and end of study 6 months
Trial Locations
- Locations (1)
Accelsiors CRO and Consultancy Services
🇭🇺Budapest, Hungary