Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients
Phase 2
Completed
- Conditions
- Adult Growth Hormone Deficiency
- Interventions
- Registration Number
- NCT01822340
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- 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 week (EOW) regime administered for a period of 24 weeks initial study.
- 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 of HM10560A when administered in optimal dose range and dose frequency for additional 48 weeks (followed with 2 weeks safety follow up)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- 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 Criteria
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 HM10560A Once weekly HM10560A Cohort 5 Genotropin Once daily Genotropin Cohort 2 HM10560A Once weekly HM10560A Cohort 3 HM10560A Once weekly HM10560A Cohort 4 HM10560A Biweekly HM10560A
- Primary Outcome Measures
Name Time Method Change of IGF-I levels in function of time, and dose strengths baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months The results from each month minus baseline
- Secondary Outcome Measures
Name Time Method IGF-I SDS; changes to baseline in IGF-I SDS baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months The results from each month minus baseline
Trial Locations
- Locations (1)
Hanmi Pharmaceutical
🇭🇺Budapest, Hungary