Back to resultsSafety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients (HM10560A)
Primary Purpose
Adult Growth Hormone Deficiency
Status
Completed
Phase
Phase 2
Locations
Hungary
Study Type
Interventional
Intervention
HM10560A
Genotropin
Sponsored by
About this trial
This is an interventional treatment trial for Adult Growth Hormone Deficiency focused on measuring AGHD
Eligibility Criteria
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;
Sites / Locations
- Hanmi Pharmaceutical
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Arm Description
Once weekly HM10560A
Once weekly HM10560A
Once weekly HM10560A
Biweekly HM10560A
Once daily Genotropin
Outcomes
Primary Outcome Measures
Change of IGF-I levels in function of time, and dose strengths
The results from each month minus baseline
Secondary Outcome Measures
IGF-I SDS; changes to baseline in IGF-I SDS
The results from each month minus baseline
Full Information
NCT ID
NCT01822340
First Posted
March 25, 2013
Last Updated
February 17, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT01822340
Brief Title
Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients
Acronym
HM10560A
Official Title
A Phase II, Randomized, Active Controlled, Open Label Study of Safety and Efficacy of HM10560A a Long-acting rhGH-HMC001 Conjugate in Treatment of Subjects Suffering From Adult Growth Hormone Deficiency (AGHD)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Growth Hormone Deficiency
Keywords
AGHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Once weekly HM10560A
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Once weekly HM10560A
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Once weekly HM10560A
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Biweekly HM10560A
Arm Title
Cohort 5
Arm Type
Active Comparator
Arm Description
Once daily Genotropin
Intervention Type
Drug
Intervention Name(s)
HM10560A
Other Intervention Name(s)
LAPS-rhGH
Intervention Description
Once weekly HM10560A
Intervention Type
Drug
Intervention Name(s)
Genotropin
Other Intervention Name(s)
Genotropin 5.3mg
Intervention Description
Once daily Genotropin
Primary Outcome Measure Information:
Title
Change of IGF-I levels in function of time, and dose strengths
Description
The results from each month minus baseline
Time Frame
baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months
Secondary Outcome Measure Information:
Title
IGF-I SDS; changes to baseline in IGF-I SDS
Description
The results from each month minus baseline
Time Frame
baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Facility Information:
Facility Name
Hanmi Pharmaceutical
City
Budapest
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients
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