Status:
COMPLETED
Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Adult Growth Hormone Deficiency
Eligibility:
All Genders
23-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/ Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and one dose on every other...
Detailed Description
* To select the optimal dose and dosing regimen of HM10560A for the subsequent phase III study on the basis of the safety and PK/PD profile after 24 weeks of treatment * To assess the long term safety...
Eligibility Criteria
Inclusion
- GHDA subjects, males and females, of age between 23 and 60 years as defined in the Consensus Guidelines for the Diagnosis and Treatment of Adults with GH Deficiency II (2007) as well as American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Hormone Use in Growth Hormone-Deficient Adults and Transition Patients (2009);
- r-hGHdrug naïve or any registered or investigational r-hGH replacement therapy was not given for more than 6 months before the screening.
- Body Mass Index (BMI, kg/m2) of both male and female patients must be between 22.0 to 35.0 kg/m2.
- Female patients must have a negative serum pregnancy test at inclusion.
- Confirmed to be negative for anti r-hGH antibodies at the time of screening.
- Willing and able to provide written informed consent prior to performing any study procedures.
Exclusion
- Patients with childhood onset of GHD treated with r-hGH before the age of 18.
- Current antitumor therapy.
- Subjects presenting with any clinically significant ECG abnormality.
- Evidence of intracranial hypertension.
- Significant hepatic dysfunction (persistent elevation of alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \>1.5 x upper limit of normal).
- Pregnancy and breastfeeding;
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01822340
Start Date
October 1 2011
End Date
February 1 2016
Last Update
February 19 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hanmi Pharmaceutical
Budapest, Hungary