Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients (HM10560A)

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)

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.

Study Overview

• Status: Completed
• Conditions: Adult Growth Hormone Deficiency
• Intervention / Treatment: Drug: HM10560A; Drug: Genotropin

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)

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary
    • Hanmi pharmaceutical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Once weekly HM10560A	Drug: HM10560A; Once weekly HM10560A; Other Names: LAPS-rhGH
Experimental: Cohort 2; Once weekly HM10560A	Drug: HM10560A; Once weekly HM10560A; Other Names: LAPS-rhGH
Experimental: Cohort 3; Once weekly HM10560A	Drug: HM10560A; Once weekly HM10560A; Other Names: LAPS-rhGH
Experimental: Cohort 4; Biweekly HM10560A	Drug: HM10560A; Once weekly HM10560A; Other Names: LAPS-rhGH
Active Comparator: Cohort 5; Once daily Genotropin	Drug: Genotropin; Once daily Genotropin; Other Names: Genotropin 5.3mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of IGF-I levels in function of time, and dose strengths	The results from each month minus baseline	baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGF-I SDS; changes to baseline in IGF-I SDS	The results from each month minus baseline	baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: March 25, 2013
• First Submitted That Met QC Criteria: April 1, 2013
• First Posted (Estimate): April 2, 2013

Study Record Updates

• Last Update Posted (Estimate): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 17, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: AGHD
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Pituitary Diseases; Dwarfism; Bone Diseases, Developmental; Hypopituitarism; Dwarfism, Pituitary; Endocrine System Diseases
• Other Study ID Numbers: 11-HM10560A-201